Brief Summary

RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an peripheral stem cell transplant for chronic lymphocytic leukemia.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

169

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 1998

Longer than P75 for phase_2

Geographic Reach

2 countries

53 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

14.3 years study duration

Study Start

First participant enrolled

January 1, 1998

Completed

8 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed

6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed

Last Updated

May 11, 2018

Status Verified

May 1, 2018

First QC Date

January 10, 2006

Last Update Submit

May 9, 2018

Conditions

Chronic Lymphocytic Leukemia

Keywords

stage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (2)

Safety of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant
Feasibility of PBSCT as measured by > 50% of included patients proceeding to transplant

Secondary Outcomes (5)

Safety of mobilization comprising dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) as measured by a treatment-related mortality of < 5% before transplant phase
Efficacy of Dexa-BEAM mobilization as measured by the amount of CD34+ cells > 4x10e6/kg at harvest
Complete clinical remissions by NIH criteria at 3 months following transplant
Molecular remissions by CDR3 PCR at 3 months following transplant
Progression-free survival by NIH criteria at 5 years from study entry

Study Arms (1)

High dose therapy + autologous PBSCT

EXPERIMENTAL

1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)

Biological: filgrastimDrug: carmustineDrug: cyclophosphamideDrug: cytarabineDrug: dexamethasoneDrug: etoposideDrug: fludarabine phosphateDrug: melphalanProcedure: bone marrow ablation with stem cell supportProcedure: peripheral blood stem cell transplantationRadiation: radiation therapy