Phase
Condition
Lymphoma
Leukemia
Lymphoproliferative Disorders
Treatment
BEAM-201
Clinical Study ID
Ages 18-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Ages 18 to ≤ 50 years.
Ages ≥ 1 year to < 18 years, after health authority approval.
T-ALL/T-LL that is CD7-positive (defined as at least 20% of blasts positive for CD7by flow cytometry or immunohistochemistry based on assessment of the study site'sCLIA [Clinical Laboratory Improvement Amendments of 1988] certified facility) insecond or greater relapse, first relapse post-transplant relapse, orchemotherapy-refractory disease. Specifically:
Second or greater relapse or post-transplant relapse, defined as:
- BM with ≥ 5% lymphoblasts by morphologic assessment or evidence ofextramedullary disease at screening after second documented CR; OR
- Flow cytometric confirmation of relapsed T-ALL of at least 0.1% aftersecond CR documented to have been MRD negative < 0.1%; OR
- Any detectable relapsed disease post-allogeneic HSCT with flow cytometricconfirmation of T-ALL of at least 0.1%; OR
- Biopsy confirmed evidence of relapsed T-LL on lymph node biopsy aftersecond CR; OR
- Any detectable disease post-allogeneic transplant with biopsy confirmedevidence of T-LL on lymph node biopsy
- Refractory disease, defined as:
- Primary refractory T-ALL or T-LL, defined as failure to achieve CR afterinduction chemotherapy, per investigator assessment and based onbiopsy-confirmed evidence of residual T-ALL or T-LL; OR
- Relapsed, refractory disease, defined as > 5% BM blasts orbiopsy-confirmed evidence of residual TLL after 1 course of re-inductionchemotherapy for patients who have relapsed after previously achieving aCR NOTE: Patients with mixed phenotype acute leukemia with T-cell dominantphenotype may be enrolled if the aforementioned criteria are met.
- Eligible for myeloablative conditioning for and allogeneic HSCT based on theinvestigator's assessment with an available donor identified by a FACT accreditedtransplant center.
Exclusion
Key Exclusion Criteria:
CNS involvement meeting any of the following criteria: CNS-3 disease, progressiveCNS involvement despite therapy, CNS parenchymal or cranial nerve lesions onimaging.
Clinically active CNS dysfunction or known history of irreversible neurologicaltoxicity related to prior antileukemic therapy.
Receipt of prior CD7 targeted therapy.
Systemic antileukemic therapy intended to induce or maintain remission within 14days prior to completion of screening.
Study Design
Connect with a study center
Stanford University School of Medicine
Stanford, California 94304
United StatesSite Not Available
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesSite Not Available
Colorado Blood Cancer Institute - SCRI - PPDS
Denver, Colorado 80218
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
The University of Kansas Cancer Center
Fairway, Kansas 66205
United StatesSite Not Available
Dana Farber and Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Cleveland Clinic- Taussig Cancer Center
Cleveland, Ohio 44106
United StatesSite Not Available
OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon 97239
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Sarah Cannon- TriStar Bone Marrow Transplant
Nashville, Tennessee 37203
United StatesSite Not Available
Methodist Hospital - Texas Transplant Institute
San Antonio, Texas 78229
United StatesSite Not Available
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