Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Influenza, Human

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Communicable Diseases

Respiratory Tract Infections

Orthomyxoviridae Infections

Virus Diseases

RNA Virus Infections

Respiratory Tract Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Vaccines

Interferons

Interferon-alpha

Peginterferon alfa-2a

Interferon alpha-2

Antiviral Agents

Immunologic Factors

TIV (Influenza Vaccine Trivalent Inactivated) alone

15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28.

Influenza Vaccine Trivalent Inactivated (TIV)

180 μg (0.5 ml) before receiving TIV, through a needle under the skin.

Pegylated interferon (PEGrIFN-α, Pegasys)

3 million units (0.5 ml) before receiving TIV, through a needle under the skin.

Interferon (IFNα, Roferon-A)

Amar Safdar, MD

The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in increasing the body's immune reaction against the flu virus in patients with Chronic Lymphocytic Leukemia (CLL).

The Study Drugs:

Pegylated interferon and interferon are designed to stop the growth of viruses. Pegylated interferon has a molecule that makes it last longer in the body. Standard interferon does not have this molecule that makes it last longer.

TIV is designed to prevent the flu.

Screening Test:

Before you can start treatment on this study, you will have a "screening test" to help the doctor decide if you are eligible to take part in this study. Blood (about 4 teaspoons) will be drawn for routine tests. If you have had a routine blood test in the last 4 weeks, this blood will not need to be drawn. Women who are able to have children must have a negative blood (about 1 teaspoon) blood test within 2 weeks of study entry.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups.

If you are assigned to Group 1, you will receive TIV alone. If you are assigned to Group 2, you will receive pegylated interferon with TIV. If you are assigned to Group 3, you will receive interferon with TIV.

You will have an equal chance of being assigned to any of the 3 groups. Your doctor, the study doctor, study staff, and you will know which group you are in.

Study Drug Administration:

You will receive TIV through a needle into a muscle in your arm (the arm you do not write with) on Days 1 and 28.

* If you are in Group 1, you will only receive TIV
* If you are in Group 2, you will receive pegylated interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.
* If you are in Group 3, you will receive interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.

After you are given the injection(s), you will be watched for 15 minutes in the clinic before you are allowed to go home.

You will keep a diary for 1 week (7 days) after the injection(s). In it, you will record any symptoms you may be experiencing, and you will also record your body temperature.

Study Visits:

On Day 1, blood (about 4 teaspoons) will be drawn to check your immune system's response to the flu virus.

On Day 8, you will be asked to return to the clinic and your symptom/temperature diary will be reviewed. If you cannot come to the clinic, a member of the research staff will call you to review this information. This phone call will take 15-30 minutes.

On Day 28, blood (about 4 teaspoons) will be drawn to check your immune system response to the flu virus.

On Day 56, blood (about 4 teaspoons) will be drawn to check you immune system response to the flu virus. If you live out of town and cannot return to M. D. Anderson for this visit, you may have your blood drawn at a local clinic. You will then mail the blood to the study doctor in a pre-paid envelope.

On Month 6, you will be called and asked about any side effects you may have experienced. This phone call will take 15-30 minutes.

Length of Study:

You will be considered off study after the Month 6 phone call. You will be taken off-study early if intolerable side effects or an allergic reaction occurs.

This is an investigational study. TIV, pegylated interferon, and interferon are FDA approved and commercially available. At this time, the use of pegylated interferon and standard interferon with TIV is only being used for research.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia

A Randomized, Phase I/II Clinical Trial Evaluating the Safety, Reactogenicity, and Immunogenicity of Licensed Trivalent Influenza Vaccine Administered With Recombinant Interferon Alpha Among Patients With Chronic Lymphocytic Leukemia

M.D. Anderson Cancer Center

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Myeloproliferative Disorders

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Pegylated Interferon and Imatinib

Izhar Hardan, MD

The study is controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+ CML) patients with complete cytogenetic response after more than one year of imatinib therapy. The aim is to explore a possible benefit in the addition of peg-interferon (Peg-IFN) to imatinib, in terms of the rate of achievement, molecular remission, and response duration.

Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy

Sheba Medical Center

Heart and Blood Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Quality of Life

Peginterferon alfa-2b

Pegylated Interferon

Interferon-alpha2a

Ray Powles, FRCP, FRCpath

Multiple myeloma is a rare form of malignancy in which neoplastic plasma cells accumulate in the bone marrow. Most malignant plasma cells continue to produce immunoglobulin. The activity of multiple myeloma can therefore usually be monitored easily by serial measurement of the serum paraprotein levels. Except for a few patients who receive a donor bone marrow transplant, multiple myeloma remains incurable despite intensive chemotherapy. Its course is typically marked by periods of active disease alternating with increasingly shorter remissions.

Interferons are substances produced in human cells in response to a variety of stimuli, such as viral infection. When given to myeloma patients as part of maintenance treatment , interferon-alpha 2 b (INTRONA) has been shown to be of value in prolonging the periods of remission. Until now, INTRONA could only be given as injections under the skin, three times a week. Some patients experience flu-like symptoms with each injection, particularly early on during maintenance therapy. This, as well as the chronic fatigue and even depression that INTRONA can induce may considerably reduce the quality of life of myeloma patients on interferon, so much so that sometimes this useful adjunct to chemotherapy for myeloma has to be stopped.

Recently, a new preparation of interferon namely pegylated interferon (PEG Intron) has become available. It has the advantage of being broken down much more slowly by the body and therefore only needs to be given once a week. This minimises the swings in blood interferon levels that may be responsible for some of the interferon side effects. The safety and superior tolerability of PEG Intron has already been demonstrated in patients with hepatitis C for which it now carries a licence, but not in myeloma patients. Here, we propose to study whether the quality of life and side effect profile of myeloma patients on PEG Intron is better compared to that of Intron®A.

In the main study, consenting eligible myeloma patients who are well and have been established on INTRONA maintenance therapy for at least six weeks will be randomly allocated to receive PEG Intron for three months followed by INTRONA for 3 months, or to continue with INTRONA for 3 months followed by PEG Intron for 3 months. All patients will be monitored regularly for any side effects and will be asked to fill in a quality of life questionnaire at the beginning (i.e. before receiving the first randomised treatment) and at the end of each study period (i.e. at 3 and 6 months). Initially, we are aiming at enrolling 60 patients into this part of the study.

In a smaller sub-study involving only 14 patients initially, we are proposing to investigate whether myeloma patients who need to be taken off Intron®A because of its side effects can tolerate PEG Intron more easily. Should their tolerance of PEG Intron also be poor we would stop the interferon maintenance therapy altogether. However, should PEG Intron be found to be acceptable to them, we intend to switch these patients back to the standard treatment at the end of six weeks treatment with PEG Intron to assess whether they have become more tolerant of Intron®A in the intervening period. Patients will again be monitored carefully for any side effects and will be asked to fill in three quality of life questionnaires (at 0, 6 and 12 weeks).

A Phase II Trial Comparing the Quality of Life, Tolerability and Toxicity of PEG Intron With INTRON® A in Patients With Multiple Myeloma

Royal Marsden NHS Foundation Trust

Philadelphia Chromosome

Leukemia, Myeloid, Chronic-Phase

Myeloid Leukemia

Chronic Myeloid Leukemia

Gastrointestinal Agents

Nilotinib

Lactitol

Combination of both treatments active by different means on the leukemic cells, in order to enhance the response rates of CP CML patients since diagnosis.

Nilotinib,Novartis,300 mg twice a day +Pegylated interferon 2a,Roche, 45 microg weekly starting Month 2-Month 12 or beyond according to investigator choice.

Franck Nicolini, Dr

The aim of this study is to demonstrate the safety and the efficacy of a combination of 2 treatments shown to have some efficacy in Chronic Phase Chronic Myelogenous Leukemia (CP CML) separately, but that have never been combined to date, and this combination is expected to substantially increase the molecular response rates.

Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia

"Phase II Multicenter Study Evaluating the Efficacy and the Safety of a Combination of Nilotinib Plus Pegylated Interferon Alpha 2a for de Novo Chronic Phase Chronic Myelogenous Leukemia Patients"

The trial opens for enrolment in 2011 March 7th for 18 months. Each patient will be followed for 24 months after entry.

CMR corresponds to a level of BCR-ABL transcripts \< 0.001 % (BCR-ABL/ABL ratio \< 0.001%). The BCR-ABL/ABL ratio will be analysed by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at 1, 2, 3, 6, 9, 12, 15, 18 and 24 months to study kinetics of CMR.

MMR corresponds to a level of BCR-ABL transcripts \< 0.1 % (BCR-ABL/ABL ratio \< 0.1%). The BCR-ABL/ABL ratio is analysed by RT-PCR at 1, 2, 3, 6, 9, 12, 15, 18 and 24 months to study kinetics of MMR.

Hospices Civils de Lyon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia	NCT00962715	Chronic Lymphoc...	Influenza Vacci... Pegylated inter... Interferon (IFN...	18 Years -	M.D. Anderson Cancer Center
Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy	NCT00297570	Leukemia, Myelo...	Pegylated Inter...	18 Years - 70 Years	Sheba Medical Center
A Phase II Trial Comparing the Quality of Life, Tolerability and Toxicity of PEG Intron With INTRON® A in Patients With Multiple Myeloma	NCT00323505	Multiple Myelom...	Pegylated Inter... Interferon-alph...	18 Years -	Royal Marsden NHS Foundation Trust
Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia	NCT01294618	Chronic Myeloge...	Nilotinib,Novar...	18 Years -	Hospices Civils de Lyon

Spots Global Cancer Trial Database for pegylated interferon