DT2219ARL Immunotoxin in Treating Patients With B-Cell Leukemia or Lymphoma That Has Relapsed or Not Responded to Treatment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Scott and White Hospital & Clinic
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00889408
First received: April 26, 2009
Last updated: March 13, 2012
Last verified: December 2009
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Purpose
RATIONALE: Immunotoxins, such as DT2219ARL, can find certain cancer cells and kill them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of DT2219ARL immunotoxin in treating patients with B-cell leukemia or lymphoma that has relapsed or not responded to treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: anti-CD19/CD22 bispecific ligand-directed toxin DT2219ARL Other: flow cytometry Other: immunoenzyme technique Other: immunohistochemistry staining method Other: pharmacological study |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of DT2219ARL (IND #100780), a Bispecific Chain Immunotoxin for the Treatment of CD19(+), CD22 (+) B-Lineage Leukemia or Lymphoma |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Leukemia
Lymphoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Dose-limiting toxicity [ Designated as safety issue: Yes ]
- Toxicity profile [ Designated as safety issue: Yes ]
- Maximum-tolerated dose [ Designated as safety issue: Yes ]
- Clinical response rate (complete response [CR], partial response, marrow CR) [ Designated as safety issue: No ]
- Anti-DT2219ARL antibodies at days 1, 7, 15, and 30 [ Designated as safety issue: No ]
- Serum DT2219ARL levels and half-life [ Designated as safety issue: No ]
- Pre-treatment leukemic blast and lymphoma cell CD19 and CD22 densities [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the toxicities and maximum-tolerated dose of anti-CD19/CD22 bispecific ligand-directed toxin DT2219ARL in patients with relapsed or refractory CD19+ and CD22+ B-lineage leukemia or lymphoma.
- Determine the pharmacokinetic profile (PK) (Cmax, T1/2, AUC, Cl, Vd) of DT2219ARL.
- Determine any therapeutic activity of DT2219ARL within the confines of a phase I study as determined by the change in percentage of blasts in bone marrow and peripheral blood and recovery of normal hematopoiesis.
- Measure levels of human anti-DT2219ARL antibodies.
- Determine if there is a correlation between PK parameters and toxicity or response.
- Determine if the expression of the CD19 and CD22 cell surface antigens is affected by treatment with DT2219ARL using flow cytometric analysis of lymphoblasts in peripheral blood and bone marrow or immunohistochemistry of node biopsies.
- Determine whether the CD19 and CD22 surface antigen expression on patient blasts or lymphoma cells correlate with response.
OUTLINE: This is a multicenter study.
Patients receive anti-CD19/CD22 bispecific ligand-directed toxin DT2219ARL IV over 4 hours on days 1, 3, 5, and 7 in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study for pharmacokinetic and immunologic studies. Bone marrow aspirates are collected at baseline and day 28 for CD19 and CD22 antigens expression by flow cytometric assays or enzyme immunoassays.
After completion of study therapy, patients are followed periodically.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed B-cell lineage leukemia or lymphoma
- Presence of CD19 and/or CD22 on at least 50% of the lymphoblasts or lymphoma cells obtained via bone marrow aspirate, peripheral blood as determined by flow cytometry, or node biopsy
Relapsed or refractory disease meeting the following criteria:
- Refractory to conventional therapy and other therapies of higher priority
- Relapse after autologous or allogeneic bone marrow transplantation allowed
- Leukemia patients must have peripheral blast count < 50,000/mm^3 (may be achieved via hydroxyurea cytoreduction)
- No leukemic or infectious pulmonary parenchymal disease
No CNS leukemia
- CSF < 5 WBC/μL allowed
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 12 weeks and < 6 months
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
- AST or ALT < 2.5 times ULN
- Serum albumin ≥ 3.0 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Adequate cardiac function defined as an ejection fraction of ≥ 40% by MUGA scan or echocardiography
- No uncontrolled systemic infection
- No documented seizure disorder or abnormal neurological examination
- No documented penicillin or cephalosporin allergies
PRIOR CONCURRENT THERAPY:
Recovered from prior therapy
- Patients who have recovered from prior therapy and have > 50% rise in peripheral blast count (confirmed twice) or > 50% growth of lymph nodes are immediately eligible
- At least 2 weeks since prior chemotherapy
- No other concurrent chemotherapy or radiotherapy
- No concurrent intravenous immunoglobulin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889408
Locations
| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| Scott and White Cancer Institute | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Clinical Trials Office - Scott and White Cancer Institute 800-882-4366 | |
Sponsors and Collaborators
Scott and White Hospital & Clinic
Investigators
| Principal Investigator: | Arthur E. Frankel, MD | Scott and White Hospital & Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Arthur E. Frankel, Scott and White Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00889408 History of Changes |
| Other Study ID Numbers: | CDR0000640379, S-WHITE-81714, DT2219ARL, IRB#00000706 |
| Study First Received: | April 26, 2009 |
| Last Updated: | March 13, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
refractory chronic lymphocytic leukemia childhood diffuse large cell lymphoma childhood grade III lymphomatoid granulomatosis childhood immunoblastic large cell lymphoma B-cell adult acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia recurrent childhood acute myeloid leukemia |
secondary acute myeloid leukemia B-cell chronic lymphocytic leukemia relapsing chronic myelogenous leukemia childhood chronic myelogenous leukemia cutaneous B-cell non-Hodgkin lymphoma recurrent adult grade III lymphomatoid granulomatosis Waldenström macroglobulinemia recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Immunotoxins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013