Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00290433

Recruitment Status : Completed

First Posted : February 13, 2006

Results First Posted : September 23, 2020

Last Update Posted : September 23, 2020

Sponsor:

Collaborator:

Ortho Biotech, Inc.

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Description

Brief Summary:

The goal of this clinical research study is to learn if treatment with two types of chemotherapy combinations can help to control peripheral T-cell lymphoma.

Condition or disease	Intervention/treatment	Phase
Lymphoma	Drug: Cyclophosphamide Drug: Mesna Drug: Vincristine Drug: Methotrexate Drug: Ara-C Drug: Dexamethasone Drug: G-CSF Drug: Doxil	Phase 2

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Detailed Description:

All of the drugs used in this study are commonly used in the treatment of cancer. However, using these drugs in combination is investigational.

During treatment, you will be given two different cycles of chemotherapy, which will be alternated every 21 days.

For Cycle 1, cyclophosphamide will be given by vein two times a day on Days 1,2, and 3. Each dose will take around 3 hours to give. Mesna will be given by vein nonstop over Days 1 through 3. Pegylated liposomal doxorubicin will be given by vein over 1 hour on Day 2. Vincristine will be given by vein on Days 4 and 11. Dexamethasone will be given by mouth on Days 1 through 4 and 11 through 14. Other drugs will be given before, during, and after chemotherapy to help decrease the risk of developing side effects. These drugs may be given by mouth or by injection.

For Cycle 2, methotrexate will be given by vein over 2 hours on Day 1 and over 22 hours on day 1. Cytarabine will be given by vein twice a day on Days 2 and 3. Each dose will take about 2 hours to give. Other drugs will be given before, during, and after treatment to help decrease the risk of developing side effects. These drugs may be given by mouth or by injection.

To help increase the blood counts and help decrease the risk of developing infections, your doctor may decide that treatment with filgrastim is necessary. Filgrastim may be given as once-a-day injections under the skin starting 24 hours after the end of Day 4 vincristine (Cycle 1) and starting 24 hours after the end of Cytarabine (Cycle 2). Your blood counts will be monitored and filgrastim is stopped when the levels become normal.

Cycles 1 and 2 will be alternated every 21 days. Both Cycles 1 and 2 can be given on an outpatient basis if your physician authorizes it. However, if your serum creatinine (blood test) reaches a certain level, Cycle 2 should be given on an inpatient basis.

Depending on how the disease responds, treatment may be stopped after 2,4, or 6 cycles. However, treatment may continue for up to 8 cycles.

During treatment, you will have around 2-3 tablespoons of blood collected at least once a week for routine tests.

After every 2 cycles, tumors will be measured using x-rays or other scans (CT, MRI, etc.) and bone marrow samples will be taken. Heart scans or heart function tests may also be needed if you doctor feels it is necessary.

If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

After the last cycle of chemotherapy, you will have follow-up exams scheduled. During these exams, you will have a chest x-ray and CT scans of the chest, abdomen (stomach) and pelvis (waist area), and PET scan. You will have blood collected (2-3 tablespoons) for routine tests. If your doctor feels it is necessary, you may also have a sample of bone marrow collected. You may choose to have long-term follow-up exams at M. D. Anderson or with your local physician.

This is an investigational study. All of the study drugs are approved by the FDA for cancer treatment and are commercially available. However, the use of the drugs in combination is experimental. Up to 55 participants will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	55 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
Study Start Date :	September 2003
Actual Primary Completion Date :	July 2015
Actual Study Completion Date :	July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Peripheral T-cell Lymphoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: HCVIDDOXIL Regimen Cycle 1: Cyclophosphamide by vein two times a day on Days 1,2, and 3. Mesna by vein nonstop over Days 1 through 3. Pegylated liposomal doxorubicin by vein over 1 hour on Day 2. Vincristine by vein on Days 4 and 11. Dexamethasone by mouth on Days 1 through 4 and 11 through 14. Cycle 2: Methotrexate by vein over 2 hours on Day 1 and over 22 hours on day 1. Cytarabine by vein twice a day on Days 2 and 3.	Drug: Cyclophosphamide Cycle 1: 300 mg/m^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3. Other Names: Cytoxan Neosar Drug: Mesna Cycle 1: 600 mg/m^2 by vein Continuous Infusion Over Days 1, 2, and 3. Drug: Vincristine Cycle 1: 1.4 mg/m^2 by vein On Day 4 and 11. Drug: Methotrexate Cycle 1 and 2: 200 mg/m^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1. Drug: Ara-C Cycle 1 and 2: 3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3. Other Names: Cytarabine Cytosar DepoCyt Cytosine arabinosine hydrochloride Drug: Dexamethasone Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14. Other Name: Decadron Drug: G-CSF Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine. Other Names: Filgrastim Neupogen Drug: Doxil Cycle 1: 25 mg/m^2 by vein Over 1 Hour on Day 2. Other Names: Pegylated Liposomal Doxorubicin Doxorubicin hydrochloride (lipsomal)

Arm

Intervention/treatment

Experimental: HCVIDDOXIL Regimen

Cycle 1: Cyclophosphamide by vein two times a day on Days 1,2, and 3. Mesna by vein nonstop over Days 1 through 3. Pegylated liposomal doxorubicin by vein over 1 hour on Day 2. Vincristine by vein on Days 4 and 11. Dexamethasone by mouth on Days 1 through 4 and 11 through 14.

Cycle 2: Methotrexate by vein over 2 hours on Day 1 and over 22 hours on day 1. Cytarabine by vein twice a day on Days 2 and 3.

Drug: Cyclophosphamide

Cycle 1: 300 mg/m^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3.

Other Names:

Cytoxan
Neosar

Drug: Mesna

Cycle 1: 600 mg/m^2 by vein Continuous Infusion Over Days 1, 2, and 3.

Drug: Vincristine

Cycle 1: 1.4 mg/m^2 by vein On Day 4 and 11.

Drug: Methotrexate

Cycle 1 and 2: 200 mg/m^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1.

Drug: Ara-C

Cycle 1 and 2: 3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3.

Other Names:

Cytarabine
Cytosar
DepoCyt
Cytosine arabinosine hydrochloride

Drug: Dexamethasone

Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14.

Other Name: Decadron

Drug: G-CSF

Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine.

Other Names:

Filgrastim
Neupogen

Drug: Doxil

Cycle 1: 25 mg/m^2 by vein Over 1 Hour on Day 2.

Other Names:

Pegylated Liposomal Doxorubicin
Doxorubicin hydrochloride (lipsomal)

Outcome Measures

Primary Outcome Measures :

3 Year Progression-Free Survival Rate [ Time Frame: From registration to disease progression or death, up to 3 years ]
Percentage of participants out of total treated alive with disease progression 3 years following registration. Progression-free survival (PFS) was measured from the date of study registration to the date of documented disease progression or death of any cause.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of previously untreated T-cell Non Hodgkin's Lymphomas and NK lymphomas, with the exception of cluster of differentiation antigen 30 (CD30+) alk1+ T-anaplastic large cell lymphoma (ALCL). Patients with skin involvement alone are also excluded. For patients with skin involvement as part of systemic disease, prior topical treatment only is allowed.
Patients with a performance status of 3 or less (Zubrod Scale - see Appendix D).
Serum bilirubin </= 1.5 mg/dl and serum creatinine </= 2.0 mg/dl unless due to lymphoma; Absolute neutrophil count (ANC) >/= 1000 mm^3 and platelets >/= 100,000 mm^3 unless due to lymphoma.
Cardiac ejection fraction 50% or greater by multigated radionuclide angiography (MUGA) or echocardiogram.
Ages 18 and older.
Patients must be willing to receive transfusions of blood products.

Exclusion Criteria:

Patients with CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL) or patients with skin involvement alone.
Pregnancy
HIV positive serology
Central nervous system (CNS) involvement
Co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator
Concurrent or previous malignancy whose prognosis is poor (<90% probability of survival at 5 years)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290433

Locations

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Ortho Biotech, Inc.

Investigators

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Principal Investigator:	Yasuhiro Oki, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

Publications of Results:

Chihara D, Pro B, Loghavi S, Miranda RN, Medeiros LJ, Fanale MA, Hagemeister FB, Fayad LE, Romaguera JE, Samaniego F, Neelapu SS, Younes A, Fowler NH, Rodriguez MA, Wang M, Kwak LW, McLaughlin P, Dang NH, Oki Y. Phase II study of HCVIDD/MA in patients with newly diagnosed peripheral T-cell lymphoma. Br J Haematol. 2015 Nov;171(4):509-16. doi: 10.1111/bjh.13628. Epub 2015 Aug 10.

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Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00290433
Other Study ID Numbers:	ID03-0004 NCI-2010-00445 ( Registry Identifier: NCI CTRP )
First Posted:	February 13, 2006 Key Record Dates
Results First Posted:	September 23, 2020
Last Update Posted:	September 23, 2020
Last Verified:	September 2020

Keywords provided by M.D. Anderson Cancer Center:


Lymphoma Peripheral T Cell HCVIDDOXIL Regimen ARA-C Cytosar DepoCyt Cytosine arabinosine hydrochloride Pegylated Liposomal Doxorubicin Doxorubicin hydrochloride Doxil Cyclophosphamide	Cytoxan Neosar Dexamethasone Decadron Mesna Methotrexate Vincristine G-CSF Filgrastim Neupogen

Additional relevant MeSH terms:

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Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cytarabine Dexamethasone Cyclophosphamide Doxorubicin Liposomal doxorubicin	Methotrexate Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents

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