MDACC Study Summary 2007-0483

Study Summary
No. 2007-0483:.......Blood And Marrow Transplantation; Lymphoma......Chitra M. Hosing......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2007-0483

Study Title:	STUDY CT-2007-01: Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients with Diffuse Large B-Cell Lymphoma following Autologous Stem Cell Transplantation

Physician

New Patient Referral



Name:	Chitra M. Hosing	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8750 Contact us about clinical trials

General Information



Disease Group:	Blood And Marrow Transplantation Lymphoma	Supported By:	CureTech Ltd.

Phase of Study:	Phase II	Return Visit:	Days 1, 2, 43, 85, week 1, 6, 9, 16, 30, 44, and 69

Treatment Agents:	CT-011 Monoclonal Antibody	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of this clinical research study is to learn how long CT-011 may be able to keep DLBCL from returning when CT-011 is given to patients with DLBCL after they have received autologous PBSCT and high-dose chemotherapy. The safety of this treatment will also be studied.

Study Objectives / Outcomes

Primary Endpoint:
To determine the progression-free survival of the patients, defined as the proportion of patients who have not relapsed or died within 16 months following the first CT-011 treatment (18 months following autologous PBSCT)

Secondary endpoints:
1. Evaluate the toxicity and safety of CT-011 in patients with DLBCL.
2. Evaluate the event free survival (events are defined as relapse, second malignancy or death) in patients treated with CT-011.
3. Evaluate the overall survival in patients treated with CT-011.
4. Evaluate reasons patients do not receive CT-011 treatment after transplant.
5. Monitoring the following biological and cellular markers in patients treated with CT-011:
a. Serum TNF-alpha and Interferon-gamma levels.
b. Peripheral blood lymphocyte and myeloid cell surface markers: CCR7, CD3, CD4, CD8, CD14, CD16, CD20, CD25, CD56, 45RO, 62L, 107a, CD127, B7-H1, B7-DC, HLA-DR, and PD-1.
c. Binding of CT-011 to CD4+, CD8+, and CD56+ lymphocytes
6. Evaluate the immunogenicity of CT-011 in patients with DLBCL.

Study Status Information



Study Activation / Registration Date:	01/22/2008

IRB Review and Approval Date:	10/09/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	68

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient's age is 18 years or older, both genders.

2) The patient has histologically confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage confirmed by immunohistochemistry or flow cytometry.

3) The lymphoma is chemosensitive as determined by CT or PET/CT scan performed after the most recent salvage therapy showing reduction.

4) Patients have relapsed from or have been primary refractory to prior chemotherapy or combination therapy. Relapse is defined as reappearance of disease symptoms and new lesions identified by CT scan, and/or increase of >/=50% in the size of the longest diameter of any previously involved site, or, in the sum of the product of the longest diameter (SPD) of more than one node following achievement of complete remission; primary refractory are patients who never achieved complete remission.

5) The patient is due to undergo autologous PBSCT per Investigator's decision.

6) The patient is 30 to 90 days following autologous PBSCT.

7) The lymphoma did not progress as evident by PET/CT or CT scan performed within the last 30 days compared to the PET/CT or CT-scan performed after the most recent salvage therapy.

8) If the bone marrow was positive for disease prior to transplant then it should be verified that it is negative after transplant.

9) Performance status: ECOG 0 to 1.

10) Life expectancy at least 26 weeks.

11) Hematology: WBC >/= 2.5X10^9/L; Platelets >/= 40x10^9/L.

12) Renal function: Creatinine <1.5 x the upper limit of normal (ULN).

13) Hepatic functions: Bilirubin less than 1.5 mg/dL; AST or ALT <3xULN.

14) Cardiac function: No New York Heart Association class II, III or IV disease; no arrhythmia requiring treatment.

15) Fertile patients and/or their partners must declare simultaneous use of two forms of birth control during the treatment period (3 months) and up to 4 months after the last treatment of CT-011.

16) Signed and dated written informed consent to participate in this clinical trial has been obtained.

Exclusion Criteria:

1) Serious intercurrent illness.

2) Active autoimmune disease.

3) Type 1 diabetes.

4) Known immune deficiency.

5) Clinical evidence of primary or secondary CNS involvement by lymphoma.

6) Active bacterial, fungal, or viral infection.

7) HIV positive, Hepatitis B surface antigen positive or core protein positive plus viremia, or Hepatitis C antibody positive plus viremia.

8) Pregnant or nursing (positive pregnancy test).

9) Less than 3 months following last treatment by other biological therapies including experimental drugs or regimens. As an exception, Rituxan (also known as Rituximab or MabThera) may be used as part of the conditioning regimen for autologous PBSCT.

10) Concurrent immunotherapy, chemotherapy, radiotherapy, steroid therapy, (inhaled, oral or topical steroids for treating mild to moderate asthma, allergies or ocular inflammations, typically at </=500ug/day, are allowed).

11) History of allogeneic bone marrow/stem cell transplantation.

12) Less than 4 weeks from last cytokine treatment (erythropoietin is allowed).

13) Other concurrent clinical study or investigational therapy.

Links

Registration Number: NCT00532259
Study Information on Clinical Trials Registry (clinicaltrials.gov)