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NCT01701986 · ClinicalTrials.gov registry record · Phase 1

Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma

A Phase 1 study of Refractory B-Cell Non-Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
64
Enrollment target
1
Study location

NCT01701986: Completed Phase 1 study of Refractory B-Cell Non-Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, sponsored by M.D. Anderson Cancer Center.

NCT01701986 is a Phase 1 study of Refractory B-Cell Non-Hodgkin Lymphoma and Refractory Hodgkin Lymphoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 64 participants, above the 44-participant average among 15 other Refractory B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (45% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01701986, a Phase 1 study of Refractory B-Cell Non-Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
64 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial studies the side effects and best dose of gemcitabine hydrochloride, clofarabine, and busulfan before donor stem cell transplant and to see how well it works in treating patients with B-cell or T-cell non-Hodgkin lymphoma or Hodgkin lymphoma that does not respond to treatment. Giving chemotherapy before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Primary Outcome

Dose limiting toxicity is defined as number of participants experienced grade 3-4 mucositis lasting for more than 3 days at peak severity, grade 3-4 skin toxicity lasting for more than 3 days at peak severity, occurring within 30 days from transplant, or grade 4 nonhematological/noninfectious toxicity.

Conditions Studied

Refractory B-Cell Non-Hodgkin Lymphoma Refractory Hodgkin Lymphoma Hematopoietic Cell Transplantation Recipient Refractory T-Cell Non-Hodgkin Lymphoma

Interventions

  • DRUG Busulfan
  • BIOLOGICAL Anti-Thymocyte Globulin
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
  • DRUG Clofarabine
  • PROCEDURE Allogeneic Bone Marrow Transplantation

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2012-10-25
Est. Completion 2024-06-05
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01701986 record still lists

NCT01701986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, above the 44-participant average among 15 other Refractory B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (45% higher).

The record links to 4 conditions, with Refractory B-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Busulfan is the first listed.

NCT01701986 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01701986 about?

NCT01701986 is a clinical study titled "Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma". This phase I/II trial studies the side effects and best dose of gemcitabine hydrochloride, clofarabine, and busulfan before donor stem cell transplant and to see how well it works in treating patients with B-cell or T-cell non-Hodgkin lymphoma or Hodgkin lymphoma that does not respond to treatment. ...

What is the current status of trial NCT01701986?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2012-10-25. Estimated completion is 2024-06-05.

What conditions does trial NCT01701986 study?

This clinical trial studies the following conditions: Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Hematopoietic Cell Transplantation Recipient, Refractory T-Cell Non-Hodgkin Lymphoma.

What interventions are being tested in trial NCT01701986?

The interventions under investigation include: Busulfan (DRUG), Anti-Thymocyte Globulin (BIOLOGICAL), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Clofarabine (DRUG), Allogeneic Bone Marrow Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT01701986?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01701986 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Refractory B-Cell Non-Hodgkin Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01701986's enrollment target sits among peer trials

64 3rd of 15 higher than 13 of 15 other Refractory B-Cell Non-Hodgkin Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory B-Cell Non-Hodgkin Lymphoma 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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Related registry views

Source: ClinicalTrials.gov NCT01701986, the US trial registry maintained by the National Library of Medicine. NCT01701986 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.