CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
Carmustine +14 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Relapsed or refractory lymphoma (NHL, CLL/SLL, or Hodgkin's lymphoma) after standard chemotherapy at high risk of relapse
  • ✓CLL/SLL or PLL diagnosis (including T-cell CLL or PLL)
  • ✓Must have HLA genotypically or phenotypically identical related donor or high likelihood of HLA-matched unrelated donor
  • ✓Detectable tumor on radiographic studies or bone marrow biopsy before mobilization
Key exclusion· 11
  • ✕Life expectancy severely limited by disease other than lymphoma
  • ✕Prior autologous hematopoietic stem cell transplant
  • ✕Cardiac ejection fraction <40% on MUGA or echocardiogram (or shortening fraction <26%)
  • ✕Baseline creatinine >2.0 mg/dl and creatinine clearance <50 ml/minute

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

Search/NCT00005803
NCT00005803Phase 2Completed
CompareCT.gov

A Phase I/II Study of Autologous Stem Cell Transplantation Followed by Nonmyeloablative Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Lymphoma - A Multi-center Trial

Fred Hutchinson Cancer Center·interventional·Posted Jan 27, 2003·Updated Jan 29, 2020

In Brief

A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation, and 13 other interventions for Prolymphocytic Leukemia and 13 related conditions. Completed, enrolled 76 participants across 5 sites in 2 countries.

Detailed Summary

This phase I/II trial studies how well autologous stem cell transplant followed by donor stem cell transplant works in treating patients with lymphoma that has returned or does not respond to treatment. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProlymphocytic Leukemia, Recurrent Adult Hodgkin Lymphoma, Recurrent Childhood Hodgkin Lymphoma, Recurrent Childhood Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Non-Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Small Lymphocytic Lymphoma, T-Cell Chronic Lymphocytic Leukemia, T-Cell Prolymphocytic Leukemia
CountriesGermany, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 1999
Primary CompletionJan 1, 2016
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 16.3 yearsPosted 23.4 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous transplantation

Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation

Carmustinedrug

Given IV

Cyclophosphamidedrug

Given IV

Cyclosporinedrug

Given PO

Cytarabinedrug

Given IV

Etoposidedrug

Given IV

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Melphalandrug

Given IV

Mycophenolate Mofetildrug

Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic transplantation

Peripheral Blood Stem Cell Transplantationprocedure

Undergo allogeneic transplantation

Therapeutic Autologous Lymphocytesbiological

IV donor lymphocyte infusion

Total-Body Irradiationradiation

Undergo radiotherapy