Status:
COMPLETED
DT2219ARL for Relapsed or Refractory CD19 (+), CD 22 (+) B-Lineage Leukemia Or Lymphoma
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
This is a phase I dose escalation study of DT2219ARL for the treatment of relapsed or refractory B-lineage leukemia and lymphoma. Patients will receive a single course of DT2219ARL as a 4 hour infusio...
Detailed Description
The current study was initially conducted at University of Texas and the Scott and White Cancer Institute (A. Frankel, MD - PI) and M. D. Anderson Cancer Center with 15 evaluable patients enrolled by ...
Eligibility Criteria
Inclusion
- Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node biopsy
- Disease refractory to conventional therapy and other therapies of higher priority
- Age ≥ 12 years
- Karnofsky Performance status of ≥ 60% or, if less than 16 years of age, Lansky Play Score of ≥ 60 (appendix II)
- Patients must have recovered from effects of prior therapy - at least 2 weeks should have elapsed since the last dose of chemotherapy; however patients who have recovered from the effects of previous treatment and have a \>50% rise in peripheral blast count (confirmed twice) or \> 50% growth of lymph nodes are immediately eligible - Patients who have relapsed following autologous or allogeneic BMT are eligible
- In order to prevent tumor lysis syndrome, leukemia patients must have a peripheral blast count under 50 x 109/L. This should be achieved with hydroxyurea cytoreduction, prior to starting DT2219ARL as follows - patients with peripheral blasts and a WBC \>50 x 109/L, give hydroxyurea 1-5 g daily for up to 5 days to reduce WBC below 50 x 109/L
- Adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start defined as:
- Creatinine: ≤ 1.5 x upper limit of institutional normal (ULN)
- Hepatic: SGOT (AST) or SGPT (ALT) \< 2.5 x ULN and total bilirubin \</= 1.5 x ULN
- General health: Serum albumin ≥ 3.0g/dL
- Pulmonary: PFTs \> 50% if symptomatic or prior known impairment
- Cardiac: LVEF by ECHO or MUGA ≥ 40%
- Agrees to stay within the Twin Cities metropolitan area (i.e. within 30 miles of the study center) for the duration of the treatment (at least 24 hours after the last dose) and 2) have a capable caregiver
- Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
- Voluntary written consent
Exclusion
- Presence of leukemic or infectious pulmonary parenchymal disease
- Presence of active CNS leukemia. CSF with \<5 WBC/uL will not exclude the patient
- Presence of any uncontrolled systemic infection
- Documented uncontrolled seizure disorder or abnormal neurological examination - a seizure disorder controlled with medication (i.e. no seizures in the previous 6 months) will not exclude a patient
- Documented penicillin or cephalosporin allergies
- Pregnant or lactating - Women of child bearing potential must have a negative pregnancy test within 14 days of study treatment start
Key Trial Info
Start Date :
December 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00889408
Start Date
December 2 2013
End Date
July 21 2014
Last Update
December 2 2017
Active Locations (3)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
3
Scott and White Cancer Institute
Temple, Texas, United States, 76508