NCT02360111

Brief Summary

This is a pilot study which will be done in a small number of patients. The purpose of this study is to test the safety and benefit of giving a type of chemotherapy - cyclophosphamide - after the transplant to prevent graft versus host disease (GVHD) in patients with abnormal kidney function. GVHD is one of the most common complications of a stem cell transplant .

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable leukemia

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 8, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

2.6 years

First QC Date

February 5, 2015

Results QC Date

October 1, 2018

Last Update Submit

July 22, 2019

Conditions

LeukemiaMyelodysplastic SyndromeNon-Hodgkin's Lymphoma

Keywords

GVHD ProphylaxisCyclophosphamideRenal InsufficiencyHematopoietic Stem Cell Transplant14-273

Outcome Measures

Primary Outcomes (1)

  • # GVHD (Grade II-IV) Chronic GVHD Will be Diagnosed and Graded According to the (NIH Criteria)

    Chronic GVHD will be diagnosed and graded according to the (NIH criteria) treated with standard or experimental immunosuppressive therapy.

    2 years

Secondary Outcomes (4)

  • Disease-free Survival

    2 years

  • Overall Survival

    2 years

  • # Renal Insufficiency Defined as a Calculated eGFR <60 ml/Min/1.73m2. Those With a eGFR < 30 ml/Min/1.73m2 Will be Considered Ineligible.

    2 years

  • The Occurrence of Life-threatening Opportunistic Infections

    2 years

Study Arms (1)

Post Transplant Cyclophosphamide

EXPERIMENTAL

Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.

Drug: Cyclophosphamide

Interventions

CyclophosphamideDRUG
Post Transplant Cyclophosphamide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: Patients over age 18 who are deemed eligible for transplant by their treating physician.
  • Disease status:
  • AML in ≥ 1st remission - excluding those in 1st remission with 'good risk' cytogenetic features (i.e. t(8;21), t(15;17), inv 16).
  • Secondary AML
  • ALL/LL in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL \> 2nd remission
  • CML failing to respond to, progressing on or not tolerating appropriate TKI therapy in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
  • Non-Hodgkins lymphoma with chemoresponsive disease in any of the following categories:
  • high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants or transplants requiring the use of calcineurin inhibitors.
  • any NHL with therapy responsive disease which is considered not curable outside the transplant setting and not eligible/appropriate for autologous transplant or a higher priority protocol.
  • Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or transfusion dependence, RAEB-1 and RAEB-2 and AML evolved from MDS, who are not eligible for a higher priority protocol.
  • Chronic myelomonocytic leukemia: CMML-1 and CMML-2, advanced polycythemia vera, and myelofibrosis.
  • Patients must have a healthy HLA compatible (8/8 molecularly matched related, or unrelated) donor willing to undergo BM harvesting or PBSC apheresis after G-CSF administration. BM will be the preferred graft source.
  • Patients diagnosed with any form of acute leukemia must have received induction and at least one course of consolidation chemotherapy pretransplant
  • Patients must have a Karnofsky Performance Status \> 70%
  • Patients will have a eGFR \<60 ml/min/1.73 m2
  • +6 more criteria

You may not qualify if:

  • Major surgery or irradiation within two weeks.
  • Active CNS or extramedullary malignant disease.
  • Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or HIV infection
  • Pregnant or lactating women - they are excluded, given the potential teratogenic effects of chemotherapy and agents used in the transplant.
  • Male and female patients of child-bearing potential unwilling to use effective means of contraception
  • HIV or HTLV I/II positive, hepatitis C or chronic active hepatitis B.
  • Patients who have had a previous malignancy unless they are deemed by their treating physicians to be at low risk for recurrence.
  • Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLymphoma, Non-HodgkinRenal Insufficiency

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
Dr. Ann Jakubowski, Ph.D., MD
Organization
Memorial Sloan Kettering Cancer Center
jakubowa@mskcc.org
212-639-5013

Study Officials

  • Ann Jakubowski, Ph.D., M.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 10, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

July 24, 2019

Results First Posted

November 8, 2018

Record last verified: 2019-07

Locations

US(1)