CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Carmustine +14 moredrug
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/NCT01008462
NCT01008462Phase 2Completed
CompareCT.gov

Sequential Autologous HCT / Nonmyeloablative Allogeneic HCT Using Related, HLA-Haploidentical Donors for Patients With High-Risk Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

Fred Hutchinson Cancer Center·interventional·Posted Nov 5, 2009·Updated Jun 11, 2019

In Brief

A Phase 2 clinical trial evaluating Allogeneic Bone Marrow Transplantation, Allogeneic Hematopoietic Stem Cell Transplantation, and 13 other interventions for B-Cell Prolymphocytic Leukemia and 20 related conditions. Completed, enrolled 16 participants across 2 sites.

Detailed Summary

This phase II trial studies autologous peripheral blood stem cell transplant followed by donor bone marrow transplant in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia. Autologous stem cell transplantation uses the patient's stem cells and does not cause graft versus host disease (GVHD) and has a very low risk of death, while minimizing the number of cancer cells. Peripheral blood stem cell (PBSC) transplant uses stem cells from the patient or a donor and may be able to replace immune cells that were destroyed by chemotherapy. These donated stem cells may help destroy cancer cells. Bone marrow transplant known as a nonmyeloablative transplant uses stem cells from a haploidentical family donor. Autologous peripheral blood stem cell transplant followed by donor bone marrow transplant may work better in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-Cell Prolymphocytic Leukemia, Hypodiploidy, Loss of Chromosome 17p, Plasma Cell Leukemia, Progression of Multiple Myeloma or Plasma Cell Leukemia, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Non-Hodgkin Lymphoma, Recurrent Childhood Hodgkin Lymphoma, Recurrent Childhood Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Small Lymphocytic Lymphoma, t(14;16), t(4;14), T-Cell Prolymphocytic Leukemia, Waldenstrom Macroglobulinemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 5, 2009
Enrollment StartMar 18, 2010
Primary CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 16.7 years ago

Interventions

Allogeneic Bone Marrow Transplantationprocedure

Undergo donor HCT

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo donor HCT

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous PBSC transplant

Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous-donor tandem HCT

Carmustinedrug

Given IV

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IV

Etoposidedrug

Given IV

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative study

Melphalandrug

Given IV

Mycophenolate Mofetildrug

Given PO

Peripheral Blood Stem Cell Transplantationprocedure

Undergo donor HCT

Tacrolimusdrug

Given IV or PO

Total-Body Irradiationradiation

Undergo TBI