Tissue Bank In The Department of Pathology

Ronald Levy, MD

Ph II, Multicenter, Simon 2-Stage of R788 For Relapsed or Refractory T-Cell Lymphoma

Contact Information

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Sipra Choudhury (650) 736-2563
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

This Phase II, multicenter, two-stage study aims to assess the efficacy of R788 in patients with relapsed or refractory T-cell lymphoma.

Recruiting Status:

Recruiting

Stanford Recruiting Status:

Recruiting

Condition(s):

Intervention(s):

  • Drug: R935788 (R788)

Phase:

Phase 2

Eligibility

Ages Eligible for Study:

18 years to Any Age

Genders Eligible for Study:

Male and Female

Health of Volunteers:

People with the conditions listed in this trial can participate as controls.

Key Inclusion Criteria:

1) Patients must give written informed consent to participate in this study by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.

2) Males and females, 18 years of age or older.

3) Patients must have histologically proven T-cell lymphoma (TCL), including the following specified and unspecified subtypes:
- Peripheral T-cell lymphoma, unspecified
- Anaplastic large cell lymphoma, T/null-cell, primary systemic type
- Angioimmunoblastic T-cell lymphoma
- Extranodal NK/T-cell lymphoma, unspecified or nasal type
- Adult T-cell lymphoma/leukemia (HTLV1+)
- Blastic NK-cell lymphoma
- Enteropathy-type T-cell lymphoma
- Hepatosplenic gamma delta T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
- Transformed mycosis fungoides
- T/NK-cell lymphoma, unclassifiable

4) Patients must have documented disease progression after receiving at least one prior therapeutic regimen and must be patients for whom no known curative therapy exists.

5) In the investigator?s opinion, the patient has the ability to understand the nature of the study and any hazards of participation, to communicate satisfactorily with the investigator, to participate fully in the study, and to comply with the requirements of the entire protocol.

Key Exclusion Criteria:

1) The patient has a history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator?s opinion, could affect the conduct of the study.

2) Has a B-cell lymphoma, primary CNS lymphoma, or known lymphomatous involvement of the CNS, or any other NK/T-cell leukemias/lymphomas such as:
- Precursor T-lymphoblastic lymphoma/leukemia
- T-cell prolymphocytic leukemia
- T-cell granular lymphocytic leukemia
- NK-cell leukemia
- Anaplastic large cell lymphoma, T/null-cell, primary cutaneous type
- Non-transformed mycosis fungoides
- Sezary syndrome

3) Has uncontrolled or poorly controlled hypertension
(> 160/110 mmHg).

4) Has had recent (within 1 month prior to Day 1) serious surgery or infectious disease.

5) Has a recent history (within 2 years prior to Day 1) of, or treatment for, a malignancy other than nonmelanomatous skin cancer or carcinoma in situ of the cervix.

6) Has a known positive test for Hepatitis B surface Ag, Hepatitis C, or HIV.

7) Has any of the following laboratory abnormalities:
- Bone marrow impairment: ANC < 1,000/&#541;L (1 x 109/L); platelets < 50,000/&#541;L (50 x 109/L)
- Impairment of renal function: creatinine > 1.5 mg/dL (114.4 &#956;mol/L) or calculated CrCl < 60 mL/minute (1.002 mL/s)
- Abnormal liver function: AST/ALT > 3x ULN (up to 5x ULN with liver involvement); bilirubin > 1.5 mg/dL (25.7 &#956;mol/L)

8) Has significant gastrointestinal disease (Crohn?s or ulcerative colitis) not related to the underlying lymphoma.

9) Has difficulty swallowing or malabsorption.

10) Has an ECOG performance status > 2 (Protocol Appendix II).

11) Has received chemotherapy within 4 weeks of Day 1 of treatment (6 weeks for mitomycin C and nitrosoureas).

12) Has received antibody therapy or lymphoma vaccine therapy within 6 weeks of Day 1 of treatment.

13) Has received radiotherapy within 2 weeks of Day 1 of treatment, 4 weeks if to marrow-bearing sites (sternum, pelvis).

14) Has had an auto- or allotransplantation within 90 days prior to Day 1 of treatment.

15) Has been treated with a CYP3A4 inducer/inhibitor within 3 days prior to Day 1 of treatment or is expected to require treatment with CYP3A4 inducer/inhibitor during the course of the study. Refer to Protocol Appendix III (the active metabolite of R788 is metabolized by CYP3A4, and ketoconazole increases the AUC of a dose of R788 by approximately 2-fold).

16) Has received systemic steroids at a dose greater than the equivalent of 10 mg/day of prednisone within 4 weeks prior to Day 1 of treatment. Systemic steroids at a dose less than the equivalent of 10 mg/day of prednisone and inhaled, nasal, and topical steroids are permitted. Intermittent dexamethasone for the treatment of nausea/emesis is also permitted.

17) Has received any other investigational therapy within 4 weeks of Day 1 of treatment.

18) Is a female of childbearing potential unless menopausal, surgically sterile, or willing to use a well established method of birth control, (oral contraceptive, mechanical barrier, long-acting hormonal agent), during the study and for 30 days thereafter.

19) Is pregnant or lactating: all females of childbearing potential must have a negative urine pregnancy test within 7 days of Day 1 of study drug administration

Additional Study Details

Official Title:

Phase II, Multicenter, Simon Two-Stage Study of R788 in Patients With Relapsed or Refractory T-Cell Lymphoma

Anticipated start date:

4/20/2009

Lead Sponsor:

Rigel Pharmaceuticals Inc

Study Type:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized

Masking:

Open

Control:

none

Assignment:

Single Group

Endpoints:

Safety/Efficacy

Primary Outcomes:

  • The primary safety endpoint for this study is the incidence and frequency of adverse events during the course of R788 treatment.
  • The primary efficacy endpoint for this study is the overall response rate (ORR) [proportion of patients with best response of complete response (CR) or partial response (PR)].

Secondary Outcomes:

  • Clinical benefit rate [proportion of patients with best response of CR, PR, or stable disease (SD)]
  • Progression free survival
  • Duration of response

Total Number to be Enrolled:

61

Total Number to be Enrolled at Stanford:

8

More Information

Trial Unique Id: SU-11242008-1351

Secondary ID(s):

  • C-935788-017
  • LYMNHL0067
  • NCT00798096

Locations & Contacts

Stanford Locations & Contacts:

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Sipra Choudhury (650) 736-2563

Non-Stanford Locations:

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated:

6/10/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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