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Protocol Details

Phase I/II Study Using Prophylactic Donor Lymphocyte Infusion Early Post-Transplant After Allogeneic Hematopoietic Cell Transplantation Using Post-Transplantation Cyclophosphamide for High-Risk Hematologic Malignancies

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 12 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women


Prophylactic Donor Lymphocyte Infusions;
Chronic Graft-Versus-Host Disease;
Immunotherapeutic Strategies;
myeloablative conditioning;
Steroid-Refractory Grade

Recruitment Keyword(s)



Hematologic Neoplasms

Investigational Drug(s)


Investigational Device(s)



Procedure/Surgery: donor lymphocyte infusion
Drug: Cyclophosphamide
Drug: Busulfan
Drug: Mycophenolate mofetil
Drug: Fludarabine
Drug: Sirolimus

Supporting Site

National Cancer Institute


People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high. Researchers want to see if giving the transplant recipient an infusion of lymphocytes (a type of white blood cell) from their transplant donor early after the transplant can reduce that risk.


To learn if giving donor lymphocytes early after a transplant will help reduce the risk of relapse for people with certain blood cancers.


Adults aged 18-65 with high-risk leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that does not respond well to standard treatments and/or has a high risk of relapse. Healthy potential bone marrow and lymphocyte donor relatives aged 12 and older are also needed.


Participants will be screened with:

Physical exam

Blood and urine tests

Spinal tap

Eye exam

Dental exam

Heart and lung tests

Imaging scans. A radioactive substance may be injected in their arm if a PET scan is needed.

Bone marrow aspiration and biopsy

Some screening tests will be repeated during the study.

Participants will stay at the NIH hospital for about 4 weeks. They will receive a central venous catheter. They will get chemotherapy and other drugs starting 6 days before transplant. Then they will have their transplant. They will receive donor white blood cells 7 days later. They will give blood, bone marrow, urine, and stool samples for research. They must stay near NIH for at least 100 days after transplant.

Participants will have periodic follow-up visits for 5 years.

Healthy donors will have 2-3 visits. They will give blood, bone marrow, white blood cells, and stool samples for research.

Participation will last for 5 years.

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Inclusion Criteria - Recipient

-Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for HCT including one of the following:

-Acute myeloid leukemia (AML) with favorable cytogenetics (t(8;21), inv(16), t(15,17)) with induction failure (persistent disease without first achieving remission of any type) or active relapse

-AML with intermediate cytogenetics (not classified as favorable or adverse) with induction failure or active relapse (AML with intermediate cytogenetics in morphologic complete remission [CR] with minimal residual disease detectable by any modality also will be eligible)

-AML with adverse cytogenetics (complex karyotype with >= 4 abnormalities) regardless of remission status

-Low risk myelodysplastic syndrome (MDS) (<= 5% blasts, including chronic myelomonocytic leukemia) with adverse cytogenetics (abnormal chromosome 7 or >= 4 abnormalities) with induction failure or active relapse

-High risk MDS (RAEB-1 or RAEB-2) with intermediate-risk cytogenetics (no abnormal chromosome 7 or < 4 abnormalities) with induction failure or active relapse

-High risk MDS (RAEB-1 or RAEB-2) with adverse cytogenetics (abnormal chromosome 7 or >= 4 abnormalities) regardless of remission status

-Acute lymphoblastic leukemia (ALL) in CR >= 2 or with induction failure or active relapse (ALL in CR1 with minimal residual disease detected also will be eligible)

-Chronic myelocytic leukemia (CML) in blast crisis phase

-Hodgkin lymphoma with stable or progressive disease

-Mantle cell lymphoma with stable or progressive disease

-Relapsed Burkitt lymphoma in CR or partial remission (PR)

-Aggressive B-cell Non-Hodgkin Lymphoma (NHL) (e.g., diffuse large B-cell lymphoma, transformed indolent B-cell lymphoma) with stable or progressive disease

-T-cell NHL with stable or progressive disease

-Multiple myeloma (MM) with induction failure as defined by failure to achieve minimal response (CR, Very Good Partial Response [VGPR], or PR) or the development of progressive disease on primary therapy, or MM with active relapse as defined by previously treated myeloma that achieved a molecular response or better that then progressed

-Age 18-65 years.

-At least one potentially suitable HLA-haploidentical or HLA-matched donor

-Karnofsky performance score >=60%

-Recipient participants must have adequate organ function as defined below:

-Cardiac ejection fraction >=45% by 2D ECHO;

-Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of >=50% predicted;

-Estimated serum creatinine clearance of >=60 ml/minute/1.73m2 calculated using eGFR in the clinical lab;

-Total bilirubin <=2X the upper limit of normal;

-Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3X the upper limit of normal.

-Myeloablative conditioning is toxic to the developing human fetus and is teratogenic. For this reason, the following measures apply:

-Women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-transplant.

-WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment.

Inclusion Criteria - Donor

-Related donor (age >=12) deemed suitable, eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood, bone marrow, and stool for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.


Exclusion Criteria - Recipient

-Subjects who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 3 weeks prior to the date of beginning conditioning.

-Prior myeloablative conditioning for autologous or allogeneic HCT.

-Active breastfeeding.

-Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is metastatic, relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment. This excludes non-melanoma skin cancers.

-Uncontrolled intercurrent illness (e.g. severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active hepatitis, uncontrolled dental infection) that in the opinion of the PI would make it unsafe to proceed with transplantation.

Exclusion Criteria - Donor


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Not Provided

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Principal Investigator

Referral Contact

For more information:

Christopher G. Kanakry, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3142
(240) 760-6171

Amy H. Chai
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4-3152
10 Center Drive
Bethesda, Maryland 20892
(301) 219-7105

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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