MDACC Study Summary 2007-0229 (Archived)

Study Summary
No. 2007-0229:.......Lymphoma......Michelle A. Fanale......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2007-0229

Study Title:	A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects (155-CL-009)

Physician

New Patient Referral



Name:	Michelle A. Fanale	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	Astella Pharma US, Inc.

Phase of Study:	Phase II	Return Visit:	Patients must return everyday during the first 7 days for the continuous infusion. During Cycle 1, Day 15 return for study assessment. Return to clinic for study assessment every cycle between days 18-21.

Treatment Agents:	YM155	Home Care:	None

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

Estimated Length of Stay in Houston:	No hospitalization required.


Description/ Intervention:	The goal of this clinical research study is to learn if YM155 can control the growth of diffuse large B-cell lymphoma. The safety of this drug will also be studied.

Study Objectives / Outcomes

Primary
To evaluate the overall response rate [Complete Remission (CR) + Partial Remission
(PR)] of YM155 per the International Working Group Criteria (IWG, 2007) during 15
cycles of treatment.

Secondary
To evaluate the efficacy, safety and tolerability of YM155 during 15 cycles of treatment.

Additional
To assess the population pharmacokinetics (PK) of YM155.
To evaluate pharmacogenomics and biomarkers in subjects that sign a separate consent.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	11/13/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	200

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) The subject is male or female, aged 18 years or older.

2) The subject has histologically confirmed primary DLBCL of any stage. A tumor biopsy sample (excisional or core) will be obtained from each subject during the Screening Period unless a historical tissue sample previously used to diagnose DLBCL can be forwarded to this study's central pathology laboratory for histological confirmation. Disease stage will be determined by the site using the Ann Arbor staging system at the Baseline Visit.

3) The subject must have been refractory to the last treatment regimen for DLBCL administered prior to entry into this study. A subject is considered refractory if any of the following occurred during or following his or her last treatment regimen. The subject failed to obtain at least a PR at anytime while receiving the last treatment regimen. The subject obtained at least a PR during the last treatment regimen, but later progressed while still on the treatment regimen.

4) This is a continuation of criteria #3. The subject obtained at least a PR to the last treatment regimen, but progressed within 6 months following completion of the treatment regimen.

5) The subject must have been previously treated with the following treatment regimens: Anthracycline-based combination chemotherapy with rituximab and Second-line combination chemotherapy. Autologous BMT or autologous PBSCT if eligible and did not refuse. Subjects that were not eligible for an autologous BMT or PBSCT or subjects that were eligible and refused the procedure are candidates for this trial. Documentation of the reason for ineligibility or refusal must be captured in the subject's source documentation.

6) The subject must have at least one measurable lesion defined as >/= 1.5 cm in the longest transverse diameter by CT scan.

7) The subject cannot have any known central nervous system (CNS) involvement as determined by the Principal Investigator through physical examination and medical history review.

8) The subject must have an ECOG performance status </= 2.

9) The subject's life expectancy must be greater than 12 weeks.

10) If the subject is female, she must be non-pregnant and non-lactating. Each site will administer a pregnancy test to any female of child-bearing potential during the Screening Period and at the Baseline Visit. Only females with negative pregnancy test results will be eligible. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period.

11) Institutional Review Board (IRB)-approved written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization for US sites, or equivalent privacy language as per national regulations, must be obtained from the subject or legally authorized representative prior to any study-related procedures.

Exclusion Criteria:

1) The subject has transformed, discordant or composite lymphoma

2) The subject has received therapy for lymphoma within 21 days prior to the first dose of YM155 (6 weeks for nitrosureas or mitomycin).

3) Within 4 weeks of the screening FDG-PET scan, the subject has had the following: Radiation therapy, Surgical procedures (except biopsies and central catheter / port placement), and Active infection (bloodstream or deep tissue)

4) The subject has inadequate marrow, hepatic and/or renal function at the Baseline Visit as noted by the following parameters: Serum creatinine >/= 1.5 x Upper Limit of Normal (ULN) or calculated serum creatinine clearance < 60 mL/min, Absolute Neutrophil Count (ANC) </= 750/mm^3 , Platelet </= 50,000/mm^3, and Alanine Transaminase (ALT) and Aspartate Transaminase (AST) >/= 2.5 x ULN; >/= 5 x ULN if secondary to liver metastases

5) The subject received > 3 prior treatment regimens. The following should be considered when determining the number of prior treatment regimens: Any planned maintenance therapy should be considered as part of the previous treatment regimen, Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the autologous BMT or autologous PBSCT as one treatment regimen.

6) The subject has received prior allogeneic BMT or allogeneic PBSCT.

7) The subject has been previously treated with YM155.

8) The subject has received other investigational therapy or procedures within 28 days prior to the first study drug administration.

9) The subject has known Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C antibody.

10) The subject has a history of other malignancy requiring treatment within 2 years prior to the first dose of YM155, except for treated basal or squamous cell carcinoma of the skin or in situ cervical cancer.

11) The subject has significant and/or uncontrolled cardiac, renal, hepatic, or other systemic disorders or significant psychological conditions that in the Investigator's judgment would jeopardize subject enrollment or compliance to the study procedures.

Links

Registration Number: NCT00498914
Study Information on Clinical Trials Registry (clinicaltrials.gov)