NCT00619645

Brief Summary

Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Jun 2007

Typical duration 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

June 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 8, 2017

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

6.3 years

First QC Date

February 20, 2008

Results QC Date

January 13, 2017

Last Update Submit

January 5, 2018

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

recurrent adult acute myeloid leukemiaadult acute lymphoblastic leukemia in remissionrefractory anemia with excess blastsrefractory anemia with ringed sideroblastsrefractory anemiarefractory cytopenia with multilineage dysplasiapreviously treated myelodysplastic syndromesadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia in remissionadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)chronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiarecurrent adult Hodgkin lymphomarefractory multiple myelomarecurrent adult acute lymphoblastic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomasecondary acute myeloid leukemiarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomarecurrent adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomarecurrent adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomarecurrent adult Burkitt lymphomastage I multiple myelomastage II multiple myelomastage III multiple myelomade novo myelodysplastic syndromessecondary myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Day 100 Transplant-related Mortality

    Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.

    24 months after day 100 transplant

Secondary Outcomes (2)

  • Number of Patients Without Progression After Day 100 Transplant

    24 months after day 100 transplant

  • Number of Patients Alive 24 Months Post Day 100 Transplant

    24 months post day 100 transplant

Study Arms (1)

RIST for Heme malignancies

OTHER

Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy

Drug: busulfanDrug: cyclosporineDrug: fludarabine phosphateDrug: mycophenolate mofetilProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantation

Interventions

busulfanDRUG
RIST for Heme malignancies
cyclosporineDRUG
RIST for Heme malignancies
fludarabine phosphateDRUG
RIST for Heme malignancies
mycophenolate mofetilDRUG
RIST for Heme malignancies
allogeneic hematopoietic stem cell transplantationPROCEDURE
RIST for Heme malignancies
peripheral blood stem cell transplantationPROCEDURE
RIST for Heme malignancies

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosed with any of the following: * Acute myeloid leukemia (AML), meeting 1 of the following criteria: * Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required) * In first complete remission (CR1) with poor-risk cytogenetics, antecedent hematological disease (i.e., myelodysplasia), or treatment-related leukemia * Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria: * Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required) * CR1 with Philadelphia chromosome or poor-risk cytogenetics * Chronic myelogenous leukemia (CML), meeting the following criteria: * First or second chronic phase * Must be documented disease progression after imatinib mesylate therapy OR documented lack of cytogenetic response 6 months post-imatinib mesylate initiation OR imatinib mesylate intolerance * Chronic lymphocytic leukemia (CLL), meeting the following criteria: * Recurrent disease after fludarabine-based therapy * Must have chemosensitive disease at the time of relapse, defined as greater than 50% reduction of WBC and lymphadenopathy * Recurrent Hodgkin lymphoma, recurrent non-Hodgkin lymphoma (NHL) (low-, intermediate-, or high-grade disease\*), or transformed NHL, meeting 1 of the following criteria: * Received prior autologous transplantation and cytoreductive therapy at the time of relapse to achieve complete remission (CR) or CR/unconfirmed (CRu) as defined by the International Workshop * Relapsed disease that required more than 2 salvage regimens to achieve CR or CRu * Recurrent multiple myeloma, meeting the following criteria: * Must have received prior autologous transplantation and demonstrate chemosensitivity at the time of relapse, defined as greater than 50% reduction of M-component or plasma-cell marrow infiltration * Myelodysplastic syndrome * Refractory anemia (RA)/RA with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD)/refractory cytopenia with multilineage dysplasia with ringed sideroblasts (RCMD-RS), or RA with excess blasts (RAEB) I, meeting the following criteria: * Must be transfusion-dependent and have an IPSS score ≥ 1.5, based on WHO criteria * No RAEB II or del(5q) * No uncontrolled CNS metastases * 5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor (both patient and donor) available PATIENT CHARACTERISTICS: * Karnofsky performance status ≥ 50% * Serum creatinine ≤ 2 mg/dL * Not pregnant * Fertile patients must use effective contraception * 50 years of age or older * Patients 18-50 years of age are eligible if meeting 1 of the following criteria: * Have a preexisting medical condition * Received prior therapy (i.e., autologous transplantation) and are considered to be too high risk for conventional myeloablative transplantation * Must be willing to accept or comprehend irreversible sterility as a side effect of therapy * No uncontrolled active infection * No psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible * Cardiac ejection fraction ≥ 30% * Corrected pulmonary-diffusing capacity ≥ 35% * No serologic evidence of infection with HIV * No decompensated liver disease with serum bilirubin \> 2.0 mg/dL 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 California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesLeukemia, Myeloid, AcuteAnemia, Refractory, with Excess of BlastsAnemia, RefractoryCongenital AbnormalitiesLeukemia, Myeloid, Chronic-PhaseLeukemia, Lymphocytic, Chronic, B-CellHodgkin DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticBurkitt Lymphoma

Interventions

BusulfanCyclosporinefludarabine phosphateMycophenolic AcidPeripheral 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, MyeloidAnemiaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, LymphoidLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Limitations and Caveats

This study was closed after only enrolling 8 patients and results were never published.

Results Point of Contact

Title
Data Manager
Organization
University of California Davis
nmahaffey@ucdavis.edu
916-734-8381

Study Officials

  • Carol M. Richman, MD

    University of California, Davis

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

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

February 20, 2008

First Posted

February 21, 2008

Study Start

June 1, 2007

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

January 10, 2018

Results First Posted

May 8, 2017

Record last verified: 2018-01

Locations

US(1)