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NCT01804634 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
A Phase 2 study of Refractory and/or Relapsed Metastatic Solid Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT01804634: Recruiting Phase 2 study of Refractory and/or Relapsed Metastatic Solid Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01804634 is a Phase 2 study of Refractory and/or Relapsed Metastatic Solid Tumors that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01804634, a Phase 2 study of Refractory and/or Relapsed Metastatic Solid Tumors, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
Safety of shortened duration immunosuppression assessed by the number of participants with non-relapse mortality (NRM) and grade III-IV acute graft versus host disease (Przepiorka criteria stages the degree of organ involvement in the skin, liver and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least sever and Stage 4+ being most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvem
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Tacrolimus
- RADIATION low dose total body irradiation
Study Locations (3)
New York
- Albert Einstein College of Medicine, Children's Hospital at Montefiore - The Bronx
- New York Medical Center/ Maria Fareri Children's Hospital - Valhalla
Maryland
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-03-27 |
| Est. Completion | 2030-01 |
| Phase | Phase 2 |
What NCT01804634 shows while recruiting
NCT01804634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Refractory and/or Relapsed Metastatic Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01804634 reports a single indexed study location in New York, Maryland.
Frequently Asked Questions
What is clinical trial NCT01804634 about?
NCT01804634 is a clinical study titled "Reduced Intensity Haploidentical BMT for High Risk Solid Tumors". 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 is the current status of trial NCT01804634?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2013-03-27. Estimated completion is 2030-01.
What conditions does trial NCT01804634 study?
This clinical trial studies the following conditions: Refractory and/or Relapsed Metastatic Solid Tumors.
What interventions are being tested in trial NCT01804634?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Melphalan (DRUG), Tacrolimus (DRUG), low dose total body irradiation (RADIATION).
Who is sponsoring clinical trial NCT01804634?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01804634 being conducted?
This trial has 3 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01804634's enrollment target sits among peer trials
60 1027th of 2000 higher than 869 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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