NCT00006252

Brief Summary

RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

19 active sites

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

First Submitted

Initial submission to the registry

September 11, 2000

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

5.9 years

First QC Date

September 11, 2000

Last Update Submit

July 15, 2016

Conditions

LeukemiaLymphoma

Keywords

refractory chronic lymphocytic leukemiastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV adult diffuse small cleaved cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomaprolymphocytic leukemiastage I mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomacontiguous stage II small lymphocytic lymphomacontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • Treatment-related mortality within the first 6 months post-transplant

    6 months post chemo initiation

Secondary Outcomes (3)

  • Response

    6 months & 12 months

  • Percentage of patients achieving complete donor chimerism or mixed donor chimerism

    90 days post transplant

  • Survival

    5 years post study entry

Study Arms (1)

Allogeneic Stem Cell Tx

EXPERIMENTAL

minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy

Drug: fludarabine phosphateDrug: CyclophosphamideBiological: PBSCDrug: G-CSFBiological: Donor lymphocytes

Interventions

fludarabine phosphateDRUG

30 mg/sq m/day IV infusion for 5 days (Days -7 thru -3)

Allogeneic Stem Cell Tx
CyclophosphamideDRUG

1 g/sq m/day IV infusion x 3 days (Days -5 thru -3)

Allogeneic Stem Cell Tx
PBSCBIOLOGICAL

2-8,000,000/kg CD34+ cells via infusion on Day 0

Allogeneic Stem Cell Tx
G-CSFDRUG

5 ug/kg/day subQ injection until ANC \> 1000/uL for 3 days beginning Day 5

Allogeneic Stem Cell Tx
Donor lymphocytesBIOLOGICAL

10,000,000 CD3+ cells/kg via infusion

Allogeneic Stem Cell Tx

Eligibility Criteria

AgeUp to 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * One of the following histologically confirmed diagnoses: * Chronic lymphocytic leukemia * Absolute lymphocytosis greater than 5,000/mm\^3 * Morphologically mature lymphocytes with less than 55% prolymphocytes * Lymphocyte phenotypic expression of CD19 and CD5 * Failed at least 1 prior regimen * Progressive lymphocytosis with more than 50% increase in peripheral lymphocytosis or a progressive lymph node or spleen enlargement (at least 25% enlargement or the appearance of new lymph nodes) that persists for at least 4 weeks despite concurrent or prior drug treatment OR * At least 1 of the following high-risk factors and not in first complete remission = 17p deletion = 11q deletion * Unmutated VH gene status * p53 mutations * Prolymphocytic leukemia (PLL) * Absolute lymphocytosis greater than 5,000/mm\^3 * Morphologically mature lymphocytes with more than 55% prolymphocytes * Low-grade non-Hodgkin's lymphoma * Small lymphocytic lymphoma * Follicular center lymphoma (grade I or II) * Diffuse (predominately small cell type) * Marginal zone, B-cell lymphoma * No transformed lymphoma * Failure of at least 1 prior regimen OR * At least 3 of the following risk factors: * Over 60 years of age * Performance status greater than 1 * LDH greater than normal * More than 1 site of extranodal disease * Disease stage III or IV * Mantle cell lymphoma * Any stage * Ineligible for protocol CALGB-59908 * At least 1 prior treatment regimen * At least 1 of the following: * Immunophenotypic expression of CD5 and CD19 and absence of CD23 * Cytogenetic analysis with presence of t(11;14) * Overexpression of cyclin D1 * Rearrangement of BCL1 gene * Responsive or stable disease to most recent prior therapy * Prior therapy for PLL not required * Must have HLA identical sibling (6/6) donor by serologic typing (A, B, DR) * No syngeneic donors * No age restriction NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * Under 70 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 500/mm\^3\* * Platelet count at least 50,000/mm\^3\* NOTE: \*Unless attributable to disease Hepatic: * Bilirubin no greater than 3 times upper limit of normal (ULN)\* * AST no greater than 3 times ULN\* NOTE: \*Unless attributable to disease Renal: * Creatinine clearance at least 40 mL/min, unless attributable to disease Cardiovascular: * LVEF at least 30% by MUGA Pulmonary: * DLCO greater than 40% * No symptomatic pulmonary disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No uncontrolled diabetes mellitus * No active serious infection * No known hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior autologous transplantation Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior surgery

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

Sponsors & Collaborators

Study Sites (19)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Veterans Affairs Medical Center - San Diego

San Diego, California, 92161, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

St. Francis Hospital

Wilmington, Delaware, 19805, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242, United States

Location

Union Hospital Cancer Center at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224-1791, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0037, United States

Location

Related Publications (1)

  • Shea T, Johnson J, Westervelt P, Farag S, McCarty J, Bashey A, Isola L, Baxter-Lowe LA, Kelly M, Owzar K, Linker C; Cancer and Leukemia Group B. Reduced-intensity allogeneic transplantation provides high event-free and overall survival in patients with advanced indolent B cell malignancies: CALGB 109901. Biol Blood Marrow Transplant. 2011 Sep;17(9):1395-403. doi: 10.1016/j.bbmt.2011.01.016. Epub 2011 Feb 3.

    PMID: 21296675RESULT

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLymphoma, Non-HodgkinLeukemia, ProlymphocyticLymphoma, Mantle-CellLymphoma, B-Cell, Marginal Zone

Interventions

fludarabine phosphateCyclophosphamideGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Thomas Shea, MD

    UNC Lineberger Comprehensive 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
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

February 1, 2001

Primary Completion

January 1, 2007

Study Completion

October 1, 2011

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

US(19)