MedTrace Logo

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

NCT01701986 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-02-28

Study results available
· View outcomes & findings →

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.

Conditions

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

Interventions

PROCEDURE

Allogeneic Bone Marrow Transplantation

Undergo allogeneic BMT

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic BMT or PBSCT

BIOLOGICAL

Anti-Thymocyte Globulin

Given IV

DRUG

Busulfan

Given IV

DRUG

Clofarabine

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Mycophenolate Mofetil

Given IV then PO

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSCT

OTHER

Pharmacological Study

Correlative studies

BIOLOGICAL

Rituximab

Given IV

DRUG

Tacrolimus

Given IV then PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Yago L Nieto, MD,PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-25
Primary Completion
2024-06-05
Completion
2024-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701986 on ClinicalTrials.gov