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Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

Primary Purpose

Lymphoma, Multiple Myeloma, Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Busulfan, Fludarabine, Cytoxan
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Acute lymphocytic leukemia (ALL), Acute myeloid leukemia (AML), Acute Leukemia, Refractory or Relapsed AML, Myelodysplastic syndrome (MDS), Chronic myeloid leukemia (CML), Chronic myelomonocytic leukemia, Hodgkin's Lymphoma, Non-Hodgkin's lymphoma, Philadelphia-negative myeloproliferative disorder, Hematologic Malignancies, Transplantation, Busulfan, Fludarabine, Cytoxan, Bone Marrow, Allogeneic, Related donor, unrelated donor

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients ages between 0 to and 65 years of age.
  • Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
  • Acute lymphocytic leukemia (ALL) in CR1 with high risk features

  • Acute myeloid leukemia (AML) in CR1 with high risk features defined as:

    i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]

  • Acute Leukemias in 2nd or greater remission
  • Refractory or Relapsed AML
  • AML transformed from MDS
  • Myelodysplastic syndrome (MDS) beyond refractory anemia
  • Chronic myeloid leukemia (CML)
  • Chronic myelomonocytic leukemia
  • Philadelphia-negative myeloproliferative disorder
  • Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
  • Multiple Myeloma-Stage III

Exclusion Criteria:

  • Prior autologous or allogeneic stem cell transplant.
  • Performance status greater than 2
  • Active infection.
  • Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
  • Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted
  • Inadequate Serum creatinine clearance <60
  • InadequatebHepatic function
  • Positive serology for HIV-1, 2 or HTLV-1, 2.
  • Pregnancy. Female patient must have negative pregnancy test

Sites / Locations

  • The Sydney Kimmel Comprehensive Cancer center
  • Marcos deLima, MD
  • Paul V. O'Donnell, M.D., Ph.D.

Outcomes

Primary Outcome Measures

To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2008
Last Updated
January 29, 2015
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
M.D. Anderson Cancer Center, Fred Hutchinson Cancer Center, Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00809276
Brief Title
Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY
Official Title
Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
M.D. Anderson Cancer Center, Fred Hutchinson Cancer Center, Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
Detailed Description
A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT) However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Multiple Myeloma, Leukemia, Myelodysplastic Syndrome
Keywords
Acute lymphocytic leukemia (ALL), Acute myeloid leukemia (AML), Acute Leukemia, Refractory or Relapsed AML, Myelodysplastic syndrome (MDS), Chronic myeloid leukemia (CML), Chronic myelomonocytic leukemia, Hodgkin's Lymphoma, Non-Hodgkin's lymphoma, Philadelphia-negative myeloproliferative disorder, Hematologic Malignancies, Transplantation, Busulfan, Fludarabine, Cytoxan, Bone Marrow, Allogeneic, Related donor, unrelated donor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Busulfan, Fludarabine, Cytoxan
Other Intervention Name(s)
BMT, Cyclophosphamide, Allogeneic, Transplantation
Intervention Description
Busulfan once a day for 4 days Fludarabine once a day for 4 days Bone marrow transplant Cytoxan two doses
Primary Outcome Measure Information:
Title
To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
Description
Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ages between 0 to and 65 years of age. Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor. Acute lymphocytic leukemia (ALL) in CR1 with high risk features Acute myeloid leukemia (AML) in CR1 with high risk features defined as: i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities] Acute Leukemias in 2nd or greater remission Refractory or Relapsed AML AML transformed from MDS Myelodysplastic syndrome (MDS) beyond refractory anemia Chronic myeloid leukemia (CML) Chronic myelomonocytic leukemia Philadelphia-negative myeloproliferative disorder Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma Multiple Myeloma-Stage III Exclusion Criteria: Prior autologous or allogeneic stem cell transplant. Performance status greater than 2 Active infection. Inadequate cardiac function; arrythmias or symptomatic cardiac disease. Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted Inadequate Serum creatinine clearance <60 InadequatebHepatic function Positive serology for HIV-1, 2 or HTLV-1, 2. Pregnancy. Female patient must have negative pregnancy test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Luznik, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
The Sydney Kimmel Comprehensive Cancer center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Marcos deLima, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Paul V. O'Donnell, M.D., Ph.D.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25267759
Citation
Kanakry CG, O'Donnell PV, Furlong T, de Lima MJ, Wei W, Medeot M, Mielcarek M, Champlin RE, Jones RJ, Thall PF, Andersson BS, Luznik L. Multi-institutional study of post-transplantation cyclophosphamide as single-agent graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation using myeloablative busulfan and fludarabine conditioning. J Clin Oncol. 2014 Nov 1;32(31):3497-505. doi: 10.1200/JCO.2013.54.0625. Epub 2014 Sep 29.
Results Reference
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Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

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