Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant
NCT ID: NCT00617929
Last Updated: 2017-12-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2008-01-31
2015-10-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with clofarabine and rituximab works in treating patients after an unsuccessful stem cell transplant.
Detailed Description
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Primary
* To determine the rate of sustained donor engraftment at 42 days and survival at 100 days post transplantation in patients treated with anti-thymocyte globulin, clofarabine, and rituximab.
Secondary
* To determine incidence of treatment-related mortality at day 100 post transplantation.
* To determine incidence of neutrophil recovery by day 42 post transplantation.
* To determine survival at day 100 and 1 year post transplantation.
* To determine the proportion of patients with chimerism at day 28 post transplantation.
* To determine incidence and severity of grades II-IV acute graft-vs-host disease by day 100 post transplantation.
OUTLINE:
* Conditioning regimen: Patients receive rituximab intravenously (IV) on day -7, anti-thymocyte globulin IV over 4-6 hours on days -6 to -4, and clofarabine IV over 1 hour on days -4 to -2.
* Hematopoietic stem cell transplantation (HSCT): Patients undergo HSCT on day 0. Patients may receive umbilical cord blood, peripheral blood stem cells, or bone marrow from unrelated or related donors.
* Graft-vs-host disease (GVHD) prophylaxis: Patients receive oral cyclosporine twice daily or cyclosporine IV every 8 hours beginning on day -3 and continuing for 100 or 180 days post transplantation followed by a taper; mycophenolate mofetil IV every 8 hours beginning on day -3 and continuing for 30 days (or 7 days after engraftment with no evidence of GVHD); and filgrastim (G-CSF) IV once daily beginning on day 1 and continuing until blood counts recover.
After completion of study therapy, patients are followed on days 100, 180, and 360.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Conditioning for Graft Failure
Primary or secondary graft failure after hematopoietic stem cell transplantation defined as a \> 50% loss of previously best donor chimerism or less than 25% donor chimerism beyond day +42 with pancytopenia and no evidence of relapse. Patients with any diagnosis, type of donor, hematopoietic cell graft or conditioning regimen should be considered for this study. Patients receive anti-thymocyte globulin, rituximab, and clofarabine.
anti-thymocyte globulin
administer 3 mg/kg intravenously (IV) over 4 hours on days -6, -5 and -4.
rituximab
administered 375 mg/m\^2 intravenously (IV) in 1 mg/mL normal saline on day -7.
clofarabine
administered 30 mg/m\^2 intravenously (IV) over 1 hour on Days -4, -3, and -2.
stem cell transplantation
administered on Day 0 per institutional guidelines.
Interventions
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anti-thymocyte globulin
administer 3 mg/kg intravenously (IV) over 4 hours on days -6, -5 and -4.
rituximab
administered 375 mg/m\^2 intravenously (IV) in 1 mg/mL normal saline on day -7.
clofarabine
administered 30 mg/m\^2 intravenously (IV) over 1 hour on Days -4, -3, and -2.
stem cell transplantation
administered on Day 0 per institutional guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Primary or secondary graft failure after hematopoietic stem cell transplantation defined as a \> 50% loss of donor chimerism from previous maximum or less than 25% donor beyond day +42 with pancytopenia and no evidence of relapse. Patients with any diagnosis, type of donor, hematopoietic cell graft or conditioning regimen should be considered for this study.
* primary graft failure is defined as:
* ANC \< 500
* BM \< 10% on two occasions (Day +21 and Day +28)
* Donor chimerism need not to be considered, provided there is no evidence of malignancy
* secondary graft failure is defined as \< 5% cellularity and ANC \< 500 for more than 7 days any time after primary engraftment).
* Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment.
* Patients or their guardian are able and willing to provide written informed consent.
* Related donors must be 2-75 years of age and in good health.
* Meets match criteria
* Able and willing to undergo cell collection procedures (bone marrow cell collection or leukapheresis)
* Not pregnant or lactating.
* HIV-1, HIV-2 negative; HTLV-1, HTLV-2 negative, Hepatitis B and C negative.
* Patients or their guardian are able and willing to provide informed consent
Exclusion Criteria
* Uncontrolled active infection defined as more than one week with no response to appropriately chosen antibiotics
* Evidence of recurrence of primary malignancy.
* Pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. Women of childbearing age must use appropriate methods as described.
* Allergy to rituximab.
* Evidence of HIV infection or positive HIV serology.
* Autologous recovery defined as defined as greater than 90% recipient PCR product in the competitive VNTR PCR performed on gradually increasing white blood cell count.
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Jakub Tolar, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-MT2007-07
Identifier Type: OTHER
Identifier Source: secondary_id
0707M11845
Identifier Type: OTHER
Identifier Source: secondary_id
2007LS072
Identifier Type: -
Identifier Source: org_study_id