NCT00002838

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 peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Dec 1995

Typical duration for phase_1 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

December 1, 1995

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
2 years until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

6.6 years

First QC Date

November 1, 1999

Last Update Submit

July 27, 2012

Conditions

Leukemia

Keywords

stage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

  • Feasibility + Toxicity of Combination Chemotherapy Plus Peripheral Stem Cell Transplantation

    Monthly

Study Arms (1)

Combination Chemotherapy + PSCT

EXPERIMENTAL

PSCT = Peripheral Stem Cell Transplantation

Biological: Filgrastim (G-CSF)Drug: CyclophosphamideDrug: Fludarabine PhosphateProcedure: Peripheral Blood Stem Cell Transplantation

Interventions

Filgrastim (G-CSF)BIOLOGICAL
Also known as: G-CSF, Neupogen
Combination Chemotherapy + PSCT
CyclophosphamideDRUG
Also known as: Cytoxan, Neosar
Combination Chemotherapy + PSCT
Fludarabine PhosphateDRUG
Also known as: Fludara
Combination Chemotherapy + PSCT
Peripheral Blood Stem Cell TransplantationPROCEDURE
Also known as: PBSCT, Stem Cell Transplant
Combination Chemotherapy + PSCT

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Advanced chronic lymphocytic leukemia (Rai stage 3 or 4) with at least one of the following high-risk factors: Beta-2 microglobulin 3 or greater Abnormalities of chromosome 17 Other cytogenetic abnormalities Refractory to fludarabine-based chemotherapy or failure to achieve complete remission after 6 courses of a fludarabine-based regimen HLA-identical sibling donor willing and able to undergo apheresis for harvest of G-CSF-stimulated peripheral blood stem cells PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Zubrod 0 or 1 Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No symptomatic cardiac disease Pulmonary: No symptomatic pulmonary disease Other: No active uncontrolled infection PRIOR CONCURRENT THERAPY: See Disease Characteristics

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

FilgrastimGranulocyte Colony-Stimulating FactorCyclophosphamidefludarabine phosphatePeripheral Blood Stem Cell TransplantationStem Cell Transplantation

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)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsHematopoietic Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Issa Khouri, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
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 16, 2004

Study Start

December 1, 1995

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

US(1)