A Study of CA-4948 in Patients With Relapsed or Refractory Hematologic Malignancies



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:December 28, 2017
End Date:December 2021
Contact:Robert Martell, MD
Email:clinicaltrials@curis.com
Phone:617-503-6500

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An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Hematologic Malignancies

This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult
patients with Relapsed or Refractory Hematologic Malignancies. The trial will be conducted in
2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or
Refractory Hematologic Malignancies, and a Dose Expansion Phase (Part B) of CA-4948 in
patients with selected RR hematologic malignancies (including NHL with and without myeloid
differentiation primary response 88 (MYD88) mutations, and AML).


Inclusion Criteria:

1. Males and females greater than or equal to 18 years of age

2. Life expectancy of at least 3 months

3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

4. Diagnosis of histopathologically confirmed hematologic malignancies. For NHL:
Confirmed B-cell NHL (as per the World Health Organization [WHO] 2016 classification
including WM/LPL). For AML: Diagnosis of histopathologically confirmed AML (as per the
World Health Organization [WHO] 2016 classification; Owen 2013) that is relapsed
and/or refractory.

5. Relapsed or refractory disease for which patients are ineligible for or have exhausted
standard therapeutic options that would be considered standard of care

Exclusion Criteria:

1. Active central nervous system (CNS) involvement of their malignancy.

2. Radiotherapy delivered to non-target lesions within one week prior to starting study
treatment or delivered to target lesions that will be followed on the study (NOTE:
prior sites of radiation will be recorded)

3. History of allogeneic stem cell transplant for NHL

4. Any prior anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy,
etc., received within 14 days prior to start of CA-4948

5. Current or planned glucocorticoid therapy, with the following exceptions:

1. Doses ≤ 10 mg/day prednisolone or equivalent is allowed, provided that the
steroid dose has been stable or tapering for at least 14 days prior to the first
dose of CA-4948

2. Inhaled, intranasal, intraarticular and topical steroids are permitted

6. Use of any investigational agent within 28 days or 5 half-lives, whichever is shorter,
prior to start of CA-4948

7. Presence of an acute or chronic toxicity resulting from prior anti-cancer therapy,
with the exception of alopecia, that has not resolved to Grade ≤ 1 within 7 days prior
to start of CA-4948 unless approved by the Medical Monitor

8. Known allergy or hypersensitivity to any component of the formulation of CA-4948 used
in this study

9. Diagnosis of acute promyelocytic leukemia (APL, M3) for AML

10. Hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of CA-4948
for AML

11. Blast transformation of CML into AML
We found this trial at
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sites
Rochester, Minnesota 55905
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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New Haven, Connecticut 06520
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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505 South 45th Street
Omaha, Nebraska 68198
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Omaha, NE
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Seattle, Washington 98104
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Seattle, WA
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