Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Leukemia, Prolymphocytic

Leukemia, Prolymphocytic, T-Cell

Leukemia, Large Granular Lymphocytic

Leukemia, Prolymphocytic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Leukemia, T-Cell

Leukemia, Lymphoid

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Richter Syndrome

Aggressive NK Cell Leukemia

T-cell Large Granular Lymphocyte Leukemia

Anna-Maria Fink, MD

Central Study Office of the German CLL Study Group

Lutz Jakobasch, MD

Michael Hallek, MD

Long term follow-up of patients with chronic lymphocytic leukemia (CLL), B-prolymphocytic leukemia (B-PLL), T-cell prolymphocytic leukemia (T-PLL), Small lymphocytic lymphoma (SLL), T/Natural Killer large granular lymphocyte leukemia (T or NK-LGL), Hairy cell leukemia (HCL) and Richter's transformation

The most frequent primary endpoint in phase III trials of CLL is progression-free survival (PFS). However, the most important endpoint is overall survival (OS) which is usually a secondary endpoint in such trials. The outcome after progression is critical and responses to second and subsequent therapies may differ between the trial arms. Therefore it is essential to assess OS in addition to PFS. In addition, late toxicities, such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), Epstein-Barr virus (EBV)-associated lymphoproliferative disease or Hodgkin's disease, late opportunistic infections and second malignancies, are increasingly seen and are likely to differ depending on the intensity of therapy. Moreover, meta-analysis of several phase III trials with long follow-periods are desirable. Similarly, valid analyses of biological disease characteristics in relation to outcome are depending on large collections of clinical data with mature follow-up.

The findings of the CLL8 study provide evidence that the addition of rituximab to chemotherapy with Fludarabine and Cyclophosphamide (FC) may prolong survival of patients with CLL. However, it also opens the question about whether applying such therapy might cause certain late toxicities and whether it improves longterm survival for patients with CLL. Moreover the outcome of subsequent therapies after various first line treatments with Fludarabine (F), FC, Bendamustine and Rituximab (BR) or Fludarabine, Cyclophosphamide and Rituximab (FCR) amongst others outside of clinical trials needs to be investigated further.

Recently published phase III trials in CLL showed median observation times ranging from 22 to 41 months, but most of the trials report observation times around 2 years only. For most of the phase III trials of the German CLL Study Group (GCLLSG) great efforts were made to implement an extended follow up in these trials, but due to administrative reasons the follow up is limited to at most 8 years. This registry should enable the collection of data of the entire course of diseases in- and outside of clinical trials.

Besides CLL other related rare lymphoproliferative malignancies will be included in this registry. On the one hand for historical on the other hand for clinical reasons these diseases are close to CLL and information about them should be gathered as best as possible.

Only limited information is available for patients with SLL, B-PLL, T-PLL, T/NK-LGL, HCL and Richter's transformation. They carry orphan disease status and long-term follow-up data is urgently needed.

To our knowledge there are no comparable registries for patients with CLL, B-PLL, T-PLL, SLL, T/NK-LGL, HCL or Richter's transformation. In order to understand and gain greater insight into the biology, the response to treatment and the outcome of very rare diseases it is extremely important to gather structured information about the patients and their disease centrally.

Registry of the German CLL Study Group

Registry of the German CLL Study Group Long Term Follow-up of Patients With CLL, B-PLL, T-PLL, SLL,T or NK-LGL, HCL and Richter's Transformation

Overall survival will be measured from date of registry entry until date of death

German CLL Study Group

Leukemia, Hairy Cell

Hairy Cell Leukemia

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Immunotoxins

Immunotoxin HA22

Immunoconjugates

Immunologic Factors

Immunotoxin therapy

CAT-8015 Immunotoxin

Biological therapy

Sylvia Quesada, RN

Steven E Coutre, MD

Simbi Acharya

Martin Tallman, MD

NCI Clinical Trials Referral

Robert J Kreitman, MD

Krzysztof Jamroziak, MD

Tadeusz Robak, Professor

Claire Dearden, MD

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia(HCL) that has not responded to chemotherapy, surgery or radiation therapy.

PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have hairy cell leukemia (HCL) that has not responded to treatment.

OUTLINE: Patients receive CAT-8015 IV over 30 minutes on days 1, 3, and 5 followed by rest. Treatment repeats every 4 weeks for up to a total of 10 courses in the absence of dose limiting toxicity, complete response or disease progression. Patients are followed at 1, 3, 6,12,15,18, 21, 24 months following the start of the last treatment cycle.

Cohorts of 3-6 patients each will receive escalating doses of recombinant CAT-8015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, between16 to 25 new patients will be added to the MTD cohort depending on how well the CAT-8015 is tolerated.

Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease

A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patient With Relapsed or Refractory Hairy Cell Leukemia (HCL)

Cambridge Antibody Technology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Registry of the German CLL Study Group	NCT02863692	CLL SLL HCL Richter´s Trans... Leukemia, Proly... Leukemia, Proly... T-LGL Leukemia NK-LGL Leukemia		18 Years -	German CLL Study Group
Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease	NCT00462189	Leukemia Hairy Cell Leuk... HCL	Immunotoxin the... CAT-8015 Immuno... Biological ther...	18 Years -	Cambridge Antibody Technology
Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease	NCT00462189	Leukemia Hairy Cell Leuk... HCL	Immunotoxin the... CAT-8015 Immuno... Biological ther...	18 Years -	Cambridge Antibody Technology

Spots Global Cancer Trial Database for hcl

Every month we try and update this database with for hcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hcl

Every month we try and update this database with for hcl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.