CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Anti-Thymocyte Globulin +10 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01701986
NCT01701986Phase 2Completed
CompareCT.gov

Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas

M.D. Anderson Cancer Center·interventional·Posted Oct 5, 2012·Updated Feb 28, 2025

In Brief

A Phase 2 clinical trial evaluating Allogeneic Bone Marrow Transplantation, Allogeneic Hematopoietic Stem Cell Transplantation, and 9 other interventions for Hematopoietic Cell Transplantation Recipient and 3 related conditions. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematopoietic Cell Transplantation Recipient, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2012
Enrollment StartOct 25, 2012
Primary CompletionJun 5, 2024
TodayJul 2, 2026
Enrollment to primary: 11.6 yearsPosted 13.7 years ago

Interventions

Allogeneic Bone Marrow Transplantationprocedure

Undergo allogeneic BMT

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic BMT or PBSCT

Anti-Thymocyte Globulinbiological

Given IV

Busulfandrug

Given IV

Clofarabinedrug

Given IV

Gemcitabine Hydrochloridedrug

Given IV

Mycophenolate Mofetildrug

Given IV then PO

Peripheral Blood Stem Cell Transplantationprocedure

Undergo allogeneic PBSCT

Pharmacological Studyother

Correlative studies

Rituximabbiological

Given IV

Tacrolimusdrug

Given IV then PO