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GMALL Registry and Collection of Biomaterial: Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult Acute Lymphoblastic Leukemia (ALL) Patients and Related Diseases Associated With a Prospective Collection of Biomaterial (GMALLregistry)

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ClinicalTrials.gov Identifier: NCT02872987
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Nicola Goekbuget, Goethe University

Brief Summary:
The GMALL registry serves the purpose of ALL research and quality assurance. The Registry collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical routine, whether or not the patient is treated within a clinical trial.

Condition or disease
Acute Lymphoblastic Leukemia Leukemia Non-Hodgkin's Lymphoma

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial
Study Start Date : February 2009
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


Group/Cohort
B-ALL/NHL
ALL/ Lymphoblastic Lymphoma (LBL)



Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 10 years ]

Secondary Outcome Measures :
  1. Event free survival [ Time Frame: up to 10 years ]
  2. Hematologic remission rate [ Time Frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis ]
  3. Molecular remission rate [ Time Frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis ]
  4. Positron Emission Tomography (PET) based remission evaluation [ Time Frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis ]
  5. Remission duration [ Time Frame: up to 10 years ]
  6. Relapse rate [ Time Frame: up to 10 years ]
  7. Disease free survival [ Time Frame: up to 10 years ]
  8. Early mortality [ Time Frame: during induction therapy with a duration of approximately 6 - 8 weeks ]
  9. Mortality in Clinical Remission (CR) [ Time Frame: up to 10 years ]
  10. Comorbidities [ Time Frame: Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified ]
  11. Quality of life assessed by Quality of Life Questionnaire (QLQ-C30) [ Time Frame: after treatment which is approximately 2.5 years from diagnosis ]
  12. Eastern Cooperative Oncology Group (ECOG) status [ Time Frame: Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified ]
  13. Toxicities assessed by CTCAE v4.03 [ Time Frame: during treatment with an approximate duration of 2.5 years from diagnosis ]

Biospecimen Description:

Collection of biomaterial (bone marrow and peripheral blood) The biomaterial samples are stored pseudonymized in the laboratory of the medical clinic II of the university hospital Frankfurt am Main. The collection intends to give physicians and scientists the possibility to have access to biomaterial for ALL related research projects.

For consignment of samples for research projects a request for use has to be placed to the GMALL Biobank. The scientific panel of the GMALL Biobank decides about the assignment of the samples.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Acute Lymphoblastic Leukemia or seleted NHL
Criteria

Inclusion Criteria:

  • Acute Lymphoblastic Leukemia (All Subtypes) if treated according to ALL protocols
  • Other Types of Leukemia (NK Cell Lymphoma/Leukemia, Biphenotypic Acute Leukemia) if treated according to ALL protocols
  • Non-Hodgkin's Lymphoma of Following Subtypes: Burkitt Lymphoma, B Cell Lymphoma, B- or T-lineage Lymphoblastic Lymphoma, Anaplastic Large Cell Lymphoma, Other NHL) if treated according to B-ALL protocols
  • Age minimum 18 yrs

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): NCT02872987


Contacts
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Contact: Nicola Gökbuget, Dr. med. +496963016365 goekbuget@em.uni-frankfurt.de
Contact: GMALL Study center gmall@em.uni-frankfurt.de

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Sponsors and Collaborators
Goethe University
Investigators
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Principal Investigator: Nicola Gökbuget, Dr. med. University Hospital of Frankfurt (Main)

Additional Information:

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Responsible Party: Nicola Goekbuget, Head of GMALL, Goethe University
ClinicalTrials.gov Identifier: NCT02872987     History of Changes
Other Study ID Numbers: GMALL_Registry
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Leukemia
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases