Symptoms and General Pathology

All Conditions

Fatigue

The patients will carry out a daily exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The patients will be supervised by medical personnel.

Supervised exercise

The patients will receive instructions about exercise and will have access to a bike ergometer to work out. However, they will not receive daily supervision or participate in a structured exercise program.

Exercise Instruction

Fernando Dimeo, MD

The study will evaluate the effects of a structured endurance exercise program on the physical performance, the mood and the complications of patients with hematological malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood stem cell transplantation.

Exercise During the Allogeneic Stem Cell Transplantation

Charite University, Berlin, Germany

Dr. Fernando Dimeo

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Hodgkin Disease

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hodgkin Lymphoma

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Melphalan

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Allogeneic Blood Stem Cell Transplantation

Paolo Anderlini, MD

1. To determine the feasibility and toxicity of employing allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy in patients with relapsed Hodgkin's disease (HD).
2. To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy.
3. To assess the antitumor activity of this approach in high-risk HD patients and the possible presence of a graft-vs-HD effect.

All patients in this study must have a plastic tube (catheter) inserted into a vein under the collarbone. Drugs and stem cells will be given through this tube.

Fludarabine will be given through the catheter once a day for four days. Patients will also receive melphalan for two days through the catheter. Patients receiving a transplant from a matched unrelated donor (i.e. not a blood relative) or a mismatched related donor (i.e. a blood relative, but not a full match) will also receive antithymocyte globulin (ATG) once a day for three days. ATG can help preventing graft-versus-host disease. All patients are expected to need blood transfusions as part of this treatment.

Beginning two days before the transplant, tacrolimus will be given through the catheter. It will be given 24 hours a day until the patient can swallow. The patient will then swallow one or more tacrolimus pills a day for about 6 months.

On the transplant day ("day 0"), the stem cells or bone marrow obtained from the donor will be infused through the catheter ("transplant"). Drugs will be given to reduce the chance of allergic reactions. Starting on day 7 after the transplant, filgrastim will be given through a needle to increase the growth of white blood cells. Methotrexate will be given by IV on days 1,3,6, 11 after the transplant. The patient may require blood transfusions for the following 2-4 weeks and sometimes longer.

Patients with progressive ("growing") Hodgkin's disease after the transplant will initially be taken off their immunosuppressive medications (tacrolimus, corticosteroids). If there is no response to this maneuver, they will be considered for infusion of additional cells from their donors, with or without preceding chemotherapy Both these maneuvers may produce a response ("shrinkage") of the tumor. Patients with persistent but stable (not "growing") disease may also be treated in a similar fashion. Potential side effects of the infusion of additional cells include graft-versus-host disease and /or a generalized drop in the blood counts. Both of these conditions can be serious or life-threatening.

Blood, urine, bone marrow and x-ray examinations will be performed as necessary to monitor the results of bone marrow transplantation. Patients may require blood and platelet transfusions. Blood tests will be done daily while hospitalized and several times a week until the blood counts recover. Bone marrow aspiration and biopsies will be performed prior to the transplant, when the donated cells show signs of engraftment, and at other times during the next 1 to 3 years to evaluate the growth of the transplant marrow, to evaluate possible recurrence of malignancy and recovery of immunity.

This is an investigational study. Up to 50 patients will be treated on this study. If the initial results are discouraging, the study may be stopped after a minimum of four patients have been enrolled.

A Study of Allogeneic Blood Stem Cell Transplantation With Purine Analog-Based Conditioning For Patients With Advanced Hodgkin's Disease

M.D. Anderson Cancer Center

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Neoplasm Metastasis

Hematologic Diseases

Bone Marrow Diseases

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Anti-Infective Agents

Tacrolimus

Cytarabine

Venetoclax

Mycophenolic Acid

Treosulfan

Amsacrine

Calcineurin Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Venetoclax treatment will be started orally once a day with food, one day before FLAMSA conditioning therapy and stopped the day before high-dose Treosulfan. The total duration of treatment with Venetoclax will be 6 days (day -11 to -6 before stem cell infusion). Patients with active disease at transplant will receive a 3-day ramp-up prephase of Ara-C (100mg total dose infused in 1h) with daily increasing doses of Venetoclax to prevent TLS during conditioning. Total treatment duration with Venetoclax in patients with active disease at transplant will be 8 days (day -13 to -6 before stem cell infusion).

Study treatment consists of the conditioning therapy including 6 or 8 days of Venetoclax treatment.

Amsacrine is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation

Ara-C is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation

Ara-C

Tacrolimus is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.

Mycophenolate Mofetil is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.

Mycophenolate Mofetil

Guido Kobbe, Prof. Dr.

Edgar Jost, Prof. Dr.

Gesine Bug, PD Dr.

Inken Hilgendorf, Prof. Dr.

Udo Holtick, PD Dr.

Mareike Verbeek, Dr.

This trial aims to find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and to evaluate whether the addition of Venetoclax to sequential conditioning with FLAMSA + Treosulfan is safe for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax)

Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML

Phase-I/II Trial to Assess the Safety and Efficacy of Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML (FLAMSAClax

maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater within the first 30 days (± 3) after transplantation

maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater until day +100 (± 7) after transplantation

Number of patients with graft failure (no donor chimerism at day +30 (± 3) after transplantation)

Incidence of aGvHD during the first 2 years after transplantation

Course of aGvHD during the first 2 years after transplantation (response/no response to steroids)

Severity of aGvHD during the first 2 years after transplantation (according to Glucksberg criteria)

Incidence of cGvHD during the first 2 years after transplantation

Course of cGvHD during the first 2 years after transplantation (response/no response to steroids)

Severity of cGvHD during the first 2 years after transplantation (according to NIH criteria)

Incidence, course and severity of VOD (according to EBMT criteria)

Time (days from day 0) to hematopoietic reconstitution (ANC\>500/µl, PLT\>20000/µl and PLT\>50000/µl)

Time (days from day 0) to transfusion independence

Best disease response within the first 100 days (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML)

Disease response and donor chimerism at day +30 (± 3), +60 (± 7) and +100 (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML)

Time (days from day 0) to complete donor chimerism in blood and marrow

Disappearance of individual molecular markers of disease (time in days from day 0)

Event-free survival (death,relapse and disease progression will be recorded as event)

Cumulative incidence of relapse (disease progression and relapse will be recorded as event)

Overall survival (OS, death will be recorded as event)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exercise During the Allogeneic Stem Cell Transplantation	NCT00883714	Fatigue Allogeneic Stem...	Supervised exer... Exercise Instru...	18 Years - 70 Years	Charite University, Berlin, Germany
Allogeneic Blood Stem Cell Transplantation	NCT00423709	Hodgkin's Disea...	Allogeneic Bloo... Fludarabine Melphalan	- 65 Years	M.D. Anderson Cancer Center
Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML	NCT05807932	Myelodysplastic... Secondary Acute... Chronic Myelomo...	Venetoclax Amsacrine Ara-C Tacrolimus Mycophenolate M...	18 Years -	Heinrich-Heine University, Duesseldorf
Exercise During the Allogeneic Stem Cell Transplantation	NCT00883714	Fatigue Allogeneic Stem...	Supervised exer... Exercise Instru...	18 Years - 70 Years	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for allogeneic blood stem cell transplantation