NCT00002844

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Mar 1991

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 1991

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

June 23, 2004

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

11.3 years

First QC Date

November 1, 1999

Last Update Submit

October 23, 2018

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemiaCyclophosphamideCytoxanNeosarBone Marrow Transplantationtotal body irradiationchronic lymphocytic leukemiaallogeneicautologous

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia

    1 year

Study Arms (1)

Cyclophosphamide + TBI + BMT

EXPERIMENTAL

TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow)

Drug: CyclophosphamideProcedure: Allogeneic Bone Marrow TransplantationProcedure: Autologous Bone Marrow TransplantationRadiation: Total Body Irradiation (TBI)

Interventions

CyclophosphamideDRUG

Daily intravenous infusions of cyclophosphamide for two days,

Also known as: Cytoxan, Neosar
Cyclophosphamide + TBI + BMT
Allogeneic Bone Marrow TransplantationPROCEDURE

After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.

Also known as: Stem Cell Transplant
Cyclophosphamide + TBI + BMT
Autologous Bone Marrow TransplantationPROCEDURE

After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.

Also known as: Stem Cell Transplant
Cyclophosphamide + TBI + BMT
Total Body Irradiation (TBI)RADIATION

Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.

Also known as: radiation therapy
Cyclophosphamide + TBI + BMT

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Chronic lymphocytic leukemia (CLL) patients after initial relapse who have achieved a complete or partial remission with fludarabine therapy or after initial relapse or progression Prolymphocytic leukemia in first remission or after relapse Patients 15-65 years old who lack an HLA-identical sibling are eligible for autologous BM transplantation Patients 16-50 years old with an HLA identical or one antigen mismatched related donor are eligible for allogeneic BM transplantation PATIENT CHARACTERISTICS: Age: 15-65 (See Disease Characteristics) Performance status: Zubrod no more than 2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: DLCO at least 50% of predicted Other: No severe concomitant medical or psychiatric illnesses PRIOR CONCURRENT THERAPY: No extensive prior radiotherapy which would prevent administration of total body radiation Patients may also participate in study MDA-DM-92082 for retroviral gene marking of the autologous marrow and blood cells

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

CyclophosphamideStem Cell TransplantationWhole-Body IrradiationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Richard E. Champlin, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 23, 2004

Study Start

March 5, 1991

Primary Completion

June 5, 2002

Study Completion

June 5, 2002

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

US(1)