Clinical Trials Logo

Clinical Trial Summary

This phase I trial is studying the safety and potential efficacy of infusing non-human leukocyte antigen (HLA) matched ex vivo expanded cord blood progenitors following treatment with clofarabine and cytarabine for patients with acute myeloid leukemia (AML). The combination of clofarabine, cytarabine (Ara-C) and granulocyte colony-stimulating factor (G-CSF) has been tested in earlier studies for the treatment of acute myeloid leukemia. In these previous clinical trials, this combination of drugs has been shown to have an anti-leukemia effect. However, the combination of clofarabine and Ara-C is profoundly myelosuppressive and immunosuppressive causing periods of neutropenia potentially lasting more than three weeks. During this period, patients are at increased risk of infections that can result in an increased risk of death. G-CSF is a growth factor that is used to help the white blood cells recover more quickly, but even with G-CSF, the use of clofarabine and Ara-C is often limited by the need to take long breaks between treatments to allow blood counts to recover. In our lab we have developed a method of growing or "expanding" blood stem cells (cells that give rise to the blood system) from umbilical cord blood. We are doing this study to find out if giving these expanded cells after chemotherapy is safe, helps the blood system recover more quickly from chemotherapy to allow shorter breaks between treatments, and decreases the risk of infection


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Assess the safety of infusing off-the-shelf non-HLA matched expanded cord blood cells following administration of cytarabine hydrochloride (GCLAC) for patients with AML.

SECONDARY OBJECTIVES:

I. Assess the ability of the product to provide temporary myeloid engraftment.

II. Assess the kinetics/persistence of potential engraftment.

III. Assess the kinetics of autologous recovery when compared to historical cohorts.

IV. Assess the development of alloimmunization.

OUTLINE:

INDUCTION THERAPY: Patients receive clofarabine intravenously (IV) over 1 hour and cytarabine hydrochloride IV over 2 hours on days 1-5. Patients receive an infusion of non-HLA matched ex vivo expanded cord blood progenitors on day 6. Filgrastim (G-CSF) is administered subcutaneously (SC) on days 0-5 and from day 7 until blood counts recover. Treatment modifications may apply according to response.

CONSOLIDATION THERAPY: Patients receive clofarabine IV over 1 hour and cytarabine hydrochloride IV over 2 hours on days 1-5. Patients also receive G-CSF SC beginning on day 0 and continuing until blood counts recover.

Patients may receive treatment for 1-4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for 2 years and then annually for 3 years. ;


Study Design


Related Conditions & MeSH terms

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult 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)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Acute Promyelocytic Leukemia (M3)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Promyelocytic, Acute
  • Recurrent Adult Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia

NCT number NCT01031368
Study type Interventional
Source Nohla Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date December 2009
Completion date October 24, 2012

See also
  Status Clinical Trial Phase
Terminated NCT01564277 - Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies Phase 2
Completed NCT01527045 - Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies Phase 2
Completed NCT02484391 - CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma Phase 1
Active, not recruiting NCT02204085 - A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Completed NCT01427881 - Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies Phase 2
Completed NCT01233921 - Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer N/A
Completed NCT01093586 - Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies Phase 2
Terminated NCT00387426 - Sunitinib in Treating Patients With Idiopathic Myelofibrosis Phase 2
Active, not recruiting NCT01056614 - Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies Phase 2
Completed NCT00093418 - S0432 Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Completed NCT00070551 - GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia Phase 1
Completed NCT00052520 - Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation Phase 1/Phase 2
Terminated NCT00052598 - Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Terminated NCT00049582 - Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia Phase 1
Completed NCT01798901 - AR-42 and Decitabine in Treating Patients With Acute Myeloid Leukemia Phase 1
Terminated NCT01876953 - Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia Phase 1/Phase 2
Completed NCT02070458 - Ixazomib, Mitoxantrone Hydrochloride, Etoposide, and Intermediate-Dose Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia Phase 1
Completed NCT02583893 - Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia Phase 2
Completed NCT01555268 - Trebananib With or Without Low-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia Phase 1