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Trial record 1 of 1 for:    WVU 11310
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Once Daily Targeted Intravenous (IV) Busulfex as Part of Reduced-toxicity Conditioning for Patients With Refractory Lymphomas Undergoing Allogeneic Transplantation

This study is currently recruiting participants.
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Verified February 2017 by West Virginia University
Sponsor:
Information provided by (Responsible Party):
West Virginia University
ClinicalTrials.gov Identifier:
NCT01203020
First received: September 13, 2010
Last updated: February 9, 2017
Last verified: February 2017
September 13, 2010
February 9, 2017
September 2010
December 2017   (Final data collection date for primary outcome measure)
To assess 1-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine. [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01203020 on ClinicalTrials.gov Archive Site
  • To record 1 and 2 year overall survival (OS) following transplantation. [ Time Frame: At 1 year and 2 years ]
  • To record 2 year PFS. [ Time Frame: 12/31/13 ]
  • To assess nonrelapse mortality (NRM) following RTC transplantation at day +100 and 1-year. [ Time Frame: 12/31/13 ]
  • To assess relapse rate following transplantation at day +100 and 1-year. [ Time Frame: 12/31/13 ]
  • To assess disease response rate (RR) following transplantation at day +100 and at 1-year. [ Time Frame: 12/31/13 ]
  • To correlate OS, PFS, RR, NRM following HPCT with systemic busulfan exposure. [ Time Frame: 12/31/13 ]
  • To assess rates of acute and chronic graft versus host disease (GVHD). [ Time Frame: 12/31/13 ]
  • Time to successful neutrophil engraftment. [ Time Frame: 12/31/13 ]
  • Time to successful platelet engraftment. [ Time Frame: 12/31/13 ]
  • To assess rates of primary and secondary graft failure. [ Time Frame: 12/31/13 ]
  • To assess rates of pulmonary toxicity and venous occlusive disease (VOD) post transplantation, and assess correlation with Busulfex exposure levels. [ Time Frame: 12/31/13 ]
  • To correlate chimerism kinetics following transplantation with Busulfex exposure levels. [ Time Frame: 12/31/13 ]
  • To record 1 and 2 year overall survival (OS) following transplantation.
  • To record 2 year PFS.
  • To assess nonrelapse mortality (NRM) following RTC transplantation at day +100 and 1-year.
  • To assess relapse rate following transplantation at day +100 and 1-year.
  • To assess disease response rate (RR) following transplantation at day +100 and at 1-year.
  • To correlate OS, PFS, RR, NRM following HSCT with systemic busulfan exposure.
  • To assess rates of acute and chronic graft versus host disease (GVHD).
  • Time to successful neutrophil engraftment.
  • Time to successful platelet engraftment.
  • To assess rates of primary and secondary graft failure.
  • To assess rates of primary and secondary graft rejection.
  • To assess rates of pulmonary toxicity and venous occlusive disease (VOD) post transplantation, and assess correlation with Busulfex exposure levels.
  • To assess lineage specific chimerism kinetics of donor cells following once daily IV Busulfex based RTC at days +30, +100, +180 and +365.
  • To correlate chimerism kinetics following transplantation with Busulfex exposure levels.
  • To determine immune reconstitution pattern at days +30, +100, +180, and +365.
  • To evaluate biologic & genetic markers associated with the malignancy, GVHD and/or the treatment.
Not Provided
Not Provided
 
Once Daily Targeted Intravenous (IV) Busulfex as Part of Reduced-toxicity Conditioning for Patients With Refractory Lymphomas Undergoing Allogeneic Transplantation
Once Daily Intravenous Busulfex as Part of Reduced-toxicity Conditioning for Patients With Relapsed/Refractory Hodgkin's and Non-Hodgkin's Lymphomas Undergoing Allogeneic Hematopoietic Progenitor Cell Transplantation - A Multicenter Phase II Study
This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT) followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.

This study hopes to learn if giving intravenous (IV) busulfan with fludarabine before (as a conditioning regimen) allogeneic hematopoietic progenitor cell transplantation (HPC) is safe and helps patients with Non—Hodgkin´s Lymphoma (NHL) and Hodgkin´s Lymphoma (HL). An HPC transplant takes cells from a donor´s bone marrow and, after chemotherapy treatment with a conditioning regimen, infuses the donor´s cells into the patient´s body. Busulfan is a strong drug that suppresses the immune system and fludarabine is a chemotherapy (cancer fighting) drug. These drugs can stop the growth of cancer cells by breaking the Deoxyribonucleic acid (DNA) or genetic material which is necessary for the growth of both healthy and cancer cells. The use of IV busulfan with fludarabine as a conditioning regimen prior to HPC transplant is investigational (not approved by the Food and Drug Administration [FDA]).

Busulfan is only given once daily by IV in this study, which is also not approved by the FDA. Patients in this study will go through standard procedures for their disease like medical history, physical exam, blood tests, Multi Gated Acquisition Scan (MUGA) scan or echocardiogram, bone marrow aspirate or biopsy, and lung functions test. Patients will be asked to donate additional blood and bone marrow for this study and for potential future research on their blood related to this study. Because of the normal procedures for HPC transplants patients in this study will be hospitalized for 4 to 6 weeks or longer and will make frequent trips to the clinic to visit the study doctor for supervision for at least one year. Each patient will also have to have a central venous catheter inserted into a large vein above the heart. This is used to give the drugs and to take blood samples.

Participation in this study will last about two years. The study expects to enroll 32 patients and will open to at least two collaborating institutions in the future. Upon initial Institutional Review Board (IRB) approval enrollment will only occur at West Virginia University (WVU). The IRB will be notified before enrollment occurs at other institutions.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Drug: Busulfan
    Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6
    Other Name: Busulfex
  • Drug: Fludarabine
    Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
    Other Names:
    • Fludarabine Monophosphate
    • Fludara
Experimental: Allogeneic hematopoietic progenitor cell transplant
Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant
Interventions:
  • Drug: Busulfan
  • Drug: Fludarabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
December 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients aged 18-70 years of age are eligible.
  2. Eligible histologies include:

    • B-cell, T-cell or NK-cell NHL refractory to frontline or salvage therapy defined as failure to achieve complete or partial remission according to standard criteria.
    • Diffuse large B-cell lymphoma relapsing within 12 months of finishing a rituximab containing first line chemotherapy regimen (regardless of response to salvage chemotherapy)or with evidence of c-myc. Primary refractory NHL (regardless of response to salvage chemotherapy).
    • Hodgkin lymphoma which is chemorefractory after at least two prior therapies.
    • Hodgkin and NHL in an untreated relapse.
    • Transformed NHL or chronic lymphocytic leukemia undergoing Richter's transformation (regardless of response to last chemotherapy). Patients with chemosensitive relapsed NHLs or Hodgkin lymphoma, but considered ineligible for curative therapy with autologous transplantation, because of (a) inability to collect stem cells, (b) prior autografting, (c) presence of myelodysplasia or (d) histology not considered curable with autografting in opinion of treating physician will be eligible.
  3. All patients must have at least one suitable HLA-matched sibling or volunteer unrelated donor available (according to institutional guidelines). HLA typing should be performed at least at serological level for HLA-A, -B, and -C and at allele level for HLA-DRB1. One antigen or allele level mismatch will be permitted between the donor and the recipient; however each donor/recipient pair must match at HLA-DRB1 at allele level.
  4. Patient must be able to provide informed consent.
  5. Left ventricular ejection fraction ≥ 40%. No uncontrolled arrhythmias or uncontrolled New York Heart Association class III-IV heart failure.
  6. Bilirubin, aspartate aminotransferase (AST), and Alanine transaminase (ALT) ≤ 3 x normal; and absence of hepatic cirrhosis.
  7. Adequate renal function as defined by a serum creatinine clearance of ≥ 40% of normal calculated by Cockcroft-Gault equation.
  8. DLCO (diffusion capacity; corrected for hemoglobin) or forced expiratory volume (FEV1) ≥ 50% of predicted.
  9. Karnofsky performance status ≥ 70.
  10. A negative pregnancy test will be required for all women of child bearing potential. Breast feeding is not permitted.

Exclusion Criteria:

  1. Patients eligible for potentially curative therapy with autologous transplantation.
  2. Patients with lymphoblastic lymphoma.
  3. Patients with positive human immunodeficiency virus (HIV) serology.
  4. Clinical evidence of uncontrolled bacterial, viral or fungal infection at the time of transplant conditioning.
  5. Prior allogeneic transplantation.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact: Pam Bunner, MT, CCRC 304-598-4511 bunnerp@wvuhealthcare.com
Contact: Crystal Stevens, MT 304-598-4512 stevensc@wvuhealthcare.com
United States
 
 
NCT01203020
WVU 11310
Yes
Not Provided
Not Provided
Not Provided
West Virginia University
West Virginia University
Not Provided
Principal Investigator: Abraham Kanate, MD West Virginia University
West Virginia University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP