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Conditioning for Graft Failure After Hematopoietic Stem Cell Transplantation


Phase 2
N/A
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

Conditioning for Graft Failure After Hematopoietic Stem Cell Transplantation


OBJECTIVES:

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.


Patient

Inclusion Criteria:



- Timing of relevant evaluations: Taking in account the need for rapid intervention, if
white blood count is less than 200 on day +20, bone marrow aspirate should be
performed on day +21. Unless there is an increase in absolute neutrophil count (ANC)
to > 500 in the following 7 days, bone marrow aspirate should be repeated on day +28.
If the white blood count is still less than 200 and bone marrow is acellular, bone
marrow (BM) or peripheral blood stem cell (PBSC) donor should be reactivated and
availability of cord blood (CB) units assessed. If the BM or PBSC donor is not
confirmed within 14 days of the request for the donation (typically second donation
from the same donor), CB unit should be used instead.

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.

Patient Exclusion Criteria:

The presence of any of the following excludes a patient from study enrollment:

- 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.

Donor

Inclusion Criteria:



- 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Donor engraftment

Outcome Description:

The process of transplanted stem cells reproducing new cells.

Outcome Time Frame:

at 42 days post transplantation

Safety Issue:

No

Principal Investigator

Jakub Tolar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2007LS072

NCT ID:

NCT00617929

Start Date:

January 2008

Completion Date:

January 2016

Related Keywords:

  • Cancer
  • chronic myelogenous leukemia
  • acute lymphoblastic leukemia
  • chronic myeloid leukemia
  • lymphoblastic leukemia
  • acute myeloid leukemia
  • chronic eosinophilic leukemia
  • primary myelofibrosis
  • chronic myelomonocytic leukemia
  • chronic neutrophilic leukemia
  • de novo myelodysplastic syndromes
  • disseminated neuroblastoma
  • juvenile myelomonocytic leukemia
  • Burkitt lymphoma
  • rhabdomyosarcoma
  • myelodysplastic syndromes
  • Hodgkin lymphoma
  • lymphoblastic lymphoma
  • breast cancer
  • follicular lymphoma
  • mantle cell lymphoma
  • marginal zone lymphoma
  • recurrent neuroblastoma
  • recurrent ovarian epithelial cancer
  • recurrent ovarian germ cell tumor
  • recurrent small lymphocytic lymphoma
  • recurrent malignant testicular germ cell tumor
  • recurrent Wilms tumor and other childhood kidney tumors
  • recurrent/refractory childhood Hodgkin lymphoma
  • refractory hairy cell leukemia
  • refractory multiple myeloma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • splenic marginal zone lymphoma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage II ovarian epithelial cancer
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III ovarian epithelial cancer
  • stage III small lymphocytic lymphoma
  • stage III malignant testicular germ cell tumor
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV breast cancer
  • stage IV chronic lymphocytic leukemia
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV ovarian epithelial cancer
  • stage IV small lymphocytic lymphoma
  • refractory chronic lymphocytic leukemia
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455