NCT00004145

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 drugs and kill more cancer cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Antithymocyte globulin may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus biological therapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Nov 1998

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

November 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

5 years

First QC Date

December 10, 1999

Last Update Submit

March 6, 2014

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomarefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarefractory chronic lymphocytic leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionrefractory anemiarefractory anemia with ringed sideroblastsrefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesstage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation

    5 years

Study Arms (1)

Arm A

EXPERIMENTAL

Fludarabine (30mg/m2/day x 5 days on days -9 to -5), cyclophosphamide (2gm/m2/day on day -5), antithymocyte globulin (10mg/kg/day x 4 days on days -5 to -2), tacrolimus (.03 mg/kg/day IVPB continuous infusion), mycophenolate mofetil (1mg PO BID, days +1 to +60), allogenic peripheral blood stem cells

Biological: anti-thymocyte globulinDrug: cyclophosphamideDrug: fludarabine phosphateProcedure: peripheral blood stem cell transplantation

Interventions

anti-thymocyte globulinBIOLOGICAL
Arm A
cyclophosphamideDRUG
Arm A
fludarabine phosphateDRUG
Arm A
peripheral blood stem cell transplantationPROCEDURE
Arm A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy for which there is no standard curative therapy, including, but not limited to: Low grade non-Hodgkin's lymphoma (NHL) Mantle cell lymphoma Chronic lymphocytic leukemia (stage II-IV) Myelodysplastic syndrome, including: Refractory anemia (RA) with ringed sideroblasts RA with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia Multiple myeloma OR Histologically proven hematologic malignancy that has failed 1 prior therapy OR is at high risk for relapse, including, but not limited to: Intermediate grade NHL High grade NHL Hodgkin's disease Acute lymphoblastic lymphoma Acute myelogenous leukemia OR Histologically proven chronic myelogenous leukemia in chronic or accelerated phase, with the following risk factors that preclude eligibility for standard allogeneic peripheral blood stem cell transplantation: Older age Poor performance status Healthy, partially related HLA 5/6 or 6/6 serologic match donor available 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: 18 to 60 or physiologic 70 Performance status: Karnofsky 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL SGOT and SGPT less than 2 times normal No active hepatitis Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: Ejection fraction greater than 45% OR Cardiac clearance Pulmonary: DLCO at least 50% predicted Other: No active infection HIV-1, HIV-2, and HTLV-1 negative Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

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 Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesHodgkin DiseaseLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseAnemia, RefractoryAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, ChronicLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal Zone

Interventions

Antilymphocyte SerumCyclophosphamidefludarabine phosphatePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersAnemiaMyelodysplastic-Myeloproliferative DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Todd M. Zimmerman, MD

    University of Chicago

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 10, 1999

First Posted

February 16, 2004

Study Start

November 1, 1998

Primary Completion

November 1, 2003

Study Completion

August 1, 2011

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations

US(1)