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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

A Phase II Trial of Reduced Intensity Conditioning and Partially HLA-mismatched (HLA-haploidentical) Related Donor Bone Marrow Transplantation for High-risk Solid Tumors

Reduced Intensity Haploidentical BMT for High Risk Solid Tumors (NCT01804634) is a Phase 2 interventional studying Refractory and/or Relapsed Metastatic Solid Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical bone marrow, post-transplant cyclophosphamide and shortened duration tacrolimus is safe and feasible for patients with very high-risk solid tumors.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Refractory and/or Relapsed Metastatic Solid Tumors and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Refractory and/or Relapsed Metastatic Solid Tumors subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Presence of a suitable related HLA-haploidentical bone marrow donor.a. The donor and recipient must be identical at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype. 1 year-50 years Patients must have a confirmed histopathologic diagnosis and be classified as high risk defined by having an expected survival of \< 10%. Examples include: - Neuroblastoma or ganglioneuroblastoma - Failure to achieve at least a PR after induction therapy with COG ANBL0532 or standard chemotherapy - Refractory to induction chemotherapy with COG ANBL0532 or standard chemotherapy - Patients with high risk disease as defined in Appendix 1 whose autologous peripheral blood stem cell product is contaminated with neuroblastoma or who do not have an autologous product available - Patients with high risk disease as defined in Appendix 1 who do not meet eligibility requirements/organ function requirements for myeloablative conditioning. Patients with \>5 identified lesions on the end of induction (COG ANBL0532 or standard chemotherapy) MIBG scan - Stage 4 rhabdomyosarcoma - Metastatic Ewing Sarcoma - Osteosarcoma with metastatic disease beyond the lungs and/or with lung metastases not amenable to resection - Desmoplastic small round cell tumor - Any other solid tumor and soft tissue sarcoma with an estimated \<10% chance of survival will be considered on a case by case basis at the departmental tumor board and/or sarcoma meeting Previous therapy: - It is expected that patients will have received upfront standard of care therapy for their respected disease - Patients who relapse after either single or tandem autologous BMT are eligible (\> 6 months must have elapsed from start of last BMT). - Patients must be recovered from the acute toxicities of any prior chemo/radio/immunotherapy or BMT ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Presence of a suitable related HLA-haploidentical bone marrow donor.a. The donor and recipient must be identical at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype. 1 year-50 years Patients must have a confirmed histopathologic diagnosis and be classified as high risk defined by having an expected survival of \< 10%. Examples include: * Neuroblastoma or ganglioneuroblastoma * Failure to achieve at least a PR after induction therapy with COG ANBL0532 or standard chemotherapy * Refractory to induction chemotherapy with COG ANBL0532 or standard chemotherapy * Patients with high risk disease as defined in Appendix 1 whose autologous peripheral blood stem cell product is contaminated with neuroblastoma or who do not have an autologous product available * Patients with high risk disease as defined in Appendix 1 who do not meet eligibility requirements/organ function requirements for myeloablative conditioning. Patients with \>5 identified lesions on the end of induction (COG ANBL0532 or standard chemotherapy) MIBG scan * Stage 4 rhabdomyosarcoma * Metastatic Ewing Sarcoma * Osteosarcoma with metastatic disease beyond the lungs and/or with lung metastases not amenable to resection * Desmoplastic small round cell tumor * Any other solid tumor and soft tissue sarcoma with an estimated \<10% chance of survival will be considered on a case by case basis at the departmental tumor board and/or sarcoma meeting Previous therapy: * It is expected that patients will have received upfront standard of care therapy for their respected disease * Patients who relapse after either single or tandem autologous BMT are eligible (\> 6 months must have elapsed from start of last BMT). * Patients must be recovered from the acute toxicities of any prior chemo/radio/immunotherapy or BMT Patients do not need to have measurable disease at time of enrollment. Patients with measurable disease must have stable disease by RECIST criteria on two scans at least 6 weeks apart. Patients with adequate organ function as measured by * Cardiac: Left ventricular ejection fraction at rest must be ≥ 35%, or shortening fraction \> 25%. * Hepatic: Bilirubin ≤ 3.0 mg/dL; and ALT, AST, and Alkaline Phosphatase \< 5 x ULN. * Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or GFR) \> 40 mL/min/1.73m2. * Pulmonary: FEV1, FVC, DLCO (diffusion capacity) \> 50% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation \> 92% on room air. Good performance status (Karnofsky/Lansky 60-100) Patients (Parents/guardians for those \<18) and donors must be able to sign consent forms. Patients must be willing to participate in all stages of treatment Criteria for recipient ineligibility Patients will not be excluded on the basis of sex, racial or ethnic background. HIV-positive Donor (donor anti-recipient) ABO incompatibility if an ABO compatible donor is available. Positive leukocytotoxic crossmatch Women of childbearing potential who currently are pregnant (HCG+) or who are not practicing adequate contraception Uncontrolled viral, bacterial, or fungal infections. Criteria for donor eligibility Age \>0.5 years Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT). Lack of recipient anti-donor HLA antibody Note: In some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry. This will be decided on a case-by-case basis by the PI and one of the immunogenetics directors. In the event that two or more eligible donors are identified, the following order of priority will be used to determine the preferred donor: 1. Medically and psychologically fit and willing to donate 2. Killer Immunoglobulin Receptor (KIR) Haplotype B Donor 3. Red blood-cell compatibility (in order of preference) 1. RBC cross-match compatible 2. Minor ABO incompatibility 3. Major ABO incompatibility 4. For CMV seronegative recipients, a CMV seronegative donor. For CMV seropositive recipients, a CMV seropositive donor is preferred. 5. When possible, HLA-mismatched donors will be prioritized over HLA-matched to maximize an allogeneic benefit. If more than one preferred donor is identified from the above list and there is no medical reason to prefer one of them, then the following guidelines are recommended: 1. If the patient is male, choose a male donor 2. Choose the youngest preferred donor 3. If the patient and family express a strong preference for a particular donor, use that one.

Treatments Being Tested

DRUG

Cyclophosphamide

preparative regimen

DRUG

Fludarabine

RADIATION

low dose total body irradiation

DRUG

Melphalan

DRUG

Tacrolimus

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Albert Einstein College of Medicine, Children's Hospital at Montefiore
The Bronx, New York, United States
New York Medical Center/ Maria Fareri Children's Hospital
Valhalla, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT01804634), the sponsor (Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT01804634 clinical trial studying?

The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical bone marrow, post-transplant cyclophosphamide and shortened duration tacrolimus is safe and feasible for patients with very high-risk solid tumors. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT01804634?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT01804634?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT01804634. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT01804634. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.