Cancer Care

CLL Research Center

Leukemia and Myeloproliferative Disorders

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)

Investigator Initiated Relapsed Phase I trial of anti-CD74 (hLL1) antibody therapy in B cell malignancies

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Sponsor

Treatment Status

Protocol Title
(click on title for more information)

1

CALGB 10404

Front line
Randomized Phase II Study of Three Fludarabine/Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia (CLL)

5

Calistoga

Relapsed
Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients with Select, Relapsed or Refractory Hematologic Malignancies

6

Investigator Initiated

Relapsed

Phase I trial of anti-CD74 (hLL1) antibody therapy in B cell malignancies

#	Sponsor	Treatment Status	Protocol Title (click on title for more information)
1	CALGB 10404	Front line	Randomized Phase II Study of Three Fludarabine/Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia (CLL)
5	Calistoga	Relapsed	Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients with Select, Relapsed or Refractory Hematologic Malignancies
6	Investigator Initiated	Relapsed	Phase I trial of anti-CD74 (hLL1) antibody therapy in B cell malignancies

1

Disease Status and/or Stage	Untreated CLL
Protocol Title	CALGB 10501: A Phase III Intergroup CLL Study of Asymptomatic Patients with Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention versus Observation with Later Treatment in the High Risk Genetic Subset with IgVH Unmutated Disease
PI	Richard Furman, MD
Contact	June Greenberg, RN 212-746-2651
Key Eligibility	Patients must have symptomatic and active intermediate or high-risk CLL. Patients must not have any prior therapy for CLL.
Treatment Overview	Patients will be randomized into one of the study groups described below: Group A - Patients will receive Fludarabine and Rituximab during induction therapy followed by observation. Group B - Patients will receive Fludarabine and Rituximab during induction therapy followed by consolidation therapy with Lenalidomide. Group C - Patients will receive Fludarabine, Rituximab, and Cyclophosphamide during induction therapy followed by observation.

5

Disease Status and/or Stage	Relapsed or Refractory Hematologic Malignancies
Protocol Title	A Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients with Select, Relapsed or Refractory Hematologic Malignancies
PI	Richard Furman, MD
Contact	June Greenberg, RN 212-746-2651
Key Eligibility	CLL patients who are refractory to or relapsed after at least 2 prior therapies, including Fludarabine, alone or in combination. Patients must be symptomatic. The study drug should be taken twice a day. The patient should take the morning dose with water on an empty stomach; food can be consumed at least an hour after dosing. The evening dose should be taken with water approximately 12 hours after the morning dose and at least 2 hours after a meal.
Treatment Overview	Each patient will be assessed for clinical response after completing 1 cycle of 28 days of treatment. Treatment may continue for up to a total of 6 cycles.

6

Disease Status and/or Stage	Recurrent Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia
Protocol Title	Phase I trial of anti-CD74 (hLL1) Antibody Therapy in B-cell malignancies
PI	John Leonard, MD
Contact	June Greenberg, RN 212-746-2651
Key Eligibility	Patients must have histologically confirmed diagnosis of recurrent B-cell Non-Hodgkin’s Lymphoma or recurrent Chronic Lymphocytic Leukemia. Patients must have received at least one prior treatment with standard chemotherapy and at least one prior treatment with Rituximab. Tumor tissue required for correlative analyses.
Treatment Overview	hLL1 (humanized anti-CD74 monoclonal antibody) administered intravenously daily, five days per week (Monday to Friday), for two weeks at one of 4 planned dose levels. Treatment occurs over 2 weeks with post-treatment evaluations over 12 weeks. Follow-up is required in all patients until resolution of any treatment related abnormalities or until relapse occurs.

7

Disease Status and/or Stage	Primary Resistant or Progressive CLL
Protocol Title	A Phase II Study of Oral Forodesine in Patients with Chronic Lymphocytic Leukemia Previously Treated with Fludarabine
PI	Richard Furman, MD
Contact	Gina Mileo, RN 212-746-6736

Last updated: January 5, 2011